URGENT MEDICAL DEVICE RECALL : /29/ C Z

Transcription

1 Custmer Cde Number: ##### Custmer Address City, State, Zip Cuntry Attentin: Risk Management Attentin: Reference: URGENT MEDICAL DEVICE RECALL March 09, 2012 Risk Management, Operating Rm Directr, Operating Rm Technicians, Physicians, Nurses, Anesthesilgists and any persnnel invlved in the use and/r setup f the device Mizuh OSI Mdular Table Systems (including Mdular Bases, Jacksn Spinal, Imaging, Lateral, & Orthpedic Tps) Mizuh OSI is issuing this cmmunicatin t ur custmers as a fllw up n ur previus Field Advisry Ntice t ntify yu that we are recalling the Mdular Table System (table) used fr patient psitining during rthpedic trauma, thracic and lumbar spine prcedures. Mizuh OSI previusly sent a Field Advisry Ntice dated July 29, 2011 t ntify ur custmers f warnings and recmmendatins fr users t cnsider fr safe use f the device. Hwever, it has been determined that Field Advisry Ntice was nt fully effective in cmmunicating the serius risks assciated with the prduct as a result f imprper training, prcedures, r use f the device. Therefre, Mizuh OSI is issuing this recall ntice t ur custmers. Imprtantly, there is n need t return any prduct r t discntinue the use f the Mdular Table System. This ntice is intended t further educate all users n certain aspects f the device and ensure awareness. During an evaluatin f the prducts it was nted that there were multiple type injury related incidents that ccurred during the use f the Mizuh OSI Mdular Table System. Althugh the affected device is a mature prduct with lngstanding use, the evaluatin revealed inadequate training and imprper use f the device. Many f these incidents invlved surgical delays, patients drpping with r falling frm the table, healthcare wrkers injured during the use f the table, failure t ensure prper pressure management techniques and patient mnitring, inadvertently causing decubitus ulcers and ther related incidents. As a summary, dcumented incidents have been recgnized t cause delays in surgeries, injuries, and serius injuries. Patient related injuries were reprted as drpping f patients with the table, patients falling frm the table, and patients sliding frm the table. Sme f these incidents were fund t be related t: Page 1 f 6 failure t ensure adequate training prir t use, which may have resulted in incrrect use f the device the table nt prperly assembled, the incrrect remval f the T pins that supprt the bttm base, instead f the T pins that supprt the tp, may result in the lwer table tp and patient falling t the flr failure t ensure all T Pins were installed, and/r assessed prir t use, failure t ensure prper maintenance, failure t assess the device prir t and after use, and failure t ensure patient mnitring and securing prir t, during and after patient transfer.

2 Reprted Incidents f injury t healthcare wrkers during the use f the table were fund t be related t: failure t prperly assemble the device, failure t ensure prper maintenance and training n use f the device and training n hw t maintain the device, failure t assess the device prir t and after use, and failure t ensure prper patient mnitring prir t, during and after patient transfer. Recgnitin f past failures is imperative t a safe and successful experience with ur prducts. In rder t ensure a safe experience fr bth the healthcare staff and the patient, Mizuh OSI is enacting this Medical Device Recall and is recmmending this ntice be psted in prminent areas, cmmunicated t all staff and ptential users f this device. Warning and Recmmendatins T ensure a safe and psitive experience fr bth the healthcare staff and patient, defined belw the fllwing general warnings and recmmendatins shuld be kept in mind at all times. Failure t cnsider these warnings and recmmendatins can result in delays in surgeries, injuries, serius injuries, and even death. Therefre, yu must ensure the device is wrking prperly prir t use, and prir t pre and pst surgery patient transfer. If yu are unsure f the device s status and/r hw t use the device, yu must cntact yur immediate supervisr fr further training and t refer t the Owner s Manual that is prvided with each device. If yu d nt have an Owner s Manual, please cntact Mizuh OSI s Custmer Resurce Grup t allcate the Owner s Manuals ( , utside the USA ). In additin, t ensure ur ntificatin effrts have been successful we must receive yur respnse cnfirming this ntice has been read and understd. A simple respnse can be sent via t recall@mizuhsi.cm that includes the wrd Urgent Medical Device Recall in the subject line and type yur cde number (fund at the tp right crner f the first page) and the respndent s name and title in the bdy f the . As indicated in the Owner s Manuals that accmpanied yur device, fllwing are ur warnings and recmmendatins fr all users t cnsider when using the devices. Warning: Incidents Fllwing are incidents that ur custmers has experienced. Imprtantly, many f these incidents can be prevented with prper user training and prper peratin f the device. Failure t ensure prper training and peratin f the device may cause harm t the patient, healthcare wrkers, and t the device. If yu are unsure f yur ability t use the device, cntact yur immediate supervisr, r cntact yur Mizuh OSI Representative fr additinal supprt. As indicated in the Owner s Manual that accmpanied yur device, it is imperative that T pins are deliberately remved nly after verificatin that the prper T pin is being remved. Thrugh ur investigatin we determined in certain incidences staff had remved the incrrect T Pin prir t and/r during surgery causing the table tp t fall frm the base resulting in patient and/r healthcare staff injuries. As indicated in the Owner s Manual that accmpanied yur device, a verificatin cunt must be perfrmed f all the T pins t cnfirm the stability f the table tp prir t patient transfer. Thrugh ur investigatin, we determined in certain incidences staff had neglected t install a T Pin t secure the table tp in place causing the tp t fall frm the base, resulting in injuries t the patient and/r healthcare wrker. Page 2 f 6

3 As indicated in the Owner s Manual that accmpanied yur device, the rtatin lcking system has a tw step lcking prcess that must be adhered t fr safe peratin. The user must verify bth lcks are engaged, and the table is secure prir t use. Thrugh ur investigatin, we determined in certain incidences staff had released bth rtatin lcks r inadvertently pushed the tilt r trend buttns allwing table t rtate (r laterally tilt) causing patient and/r healthcare staff injuries. As indicated in the Owner s Manual that accmpanied yur device, the rtatin lck shuld be tested fr security prir t patient transfer. Imprtantly, an unlcked table tp can freely rtate while transferring a patient if bth lcks are nt prperly engaged. This can create a ptential fr the table mving and the patient falling if the table s status is nt cnfirmed. Thrugh ur investigatin, we determined in certain incidences staff had neglected t cnfirm functinal status f the table prir t use causing patients and/r healthcare staff injures. Accrding t AORN Recmmended Practices: Psitining the Patient, Recmmendatin IX, all cntact pints f the patient with the table pads shuld be mnitred during the prcedure, especially fr lng duratin prcedures. Thrugh ur investigatin, we determined in certain incidences staff had neglected t cnsider the patients pre existing health cnditins, and/r failed t mnitr the patient s pressure pints causing harm t the patient (i.e. neurpathy, pre decubitus ulcers and shearing f skin). As indicated in the Owner s Manual that accmpanied yur device, Patients shuld nt be left unattended nce transferred t a mdular table tp until prperly secured in the desired psitin with the safety straps prvided. Thrugh ur investigatin, we determined in certain incidences staff had neglected t mnitr and secure the patients prir t, during r pst transfer causing patient injuries due t falling frm the table. As indicated in the Owner s Manual that accmpanied yur device, it is abslutely necessary t apply all the prper safety straps t the patient immediately after transfer and t keep them secured the entire time a patient is n the table. Thrugh ur investigatin, we determined in certain incidences staff had neglected t secure patient using safety straps prvided, causing harm t patient and/r healthcare staff injuries by patients falling frm the table. As indicated in the Owner s Manual that accmpanied yur device, it is necessary t ensure the table is rutinely inspected and maintained t ensure functinality, and failed cmpnents must be prperly replaced. Thrugh ur investigatin, we determined in certain incidences staff had neglected t prperly maintain the device causing harm t patient and/r healthcare staff. The list belw describes issues related t imprper maintenance that users shuld be made aware f and can cause harm t patient and/r healthcare staff. Failure t ensure the batteries are charged can cause damage and/r failure f table s cntrller functins. Always plug the table in and leave the pwer switch n when nt in use t ensure prper charging f the batteries. Batteries that fail t charge must be replaced. Failure t ensure the braking mechanisms are prperly maintained can cause inadvertent mvement r nn mvement f the table. Check the security and functinality f each wheel brake prir t patient transfer. Ensure the rtatinal brakes are fully functinal befre use prir t patient transfer. Page 3 f 6

4 Failure t ensure the status indicatr lights are prperly wrking can lead t functinal failures. Immediately investigate and repair any indicatr lights that are nt prperly illuminated. This will be evident when prper pre surgery inspectin is perfrmed. Device damaged by abuse can lead t sharp edges, expsed carbn cmpsite splinters r damaged safety cvers. Inspect all table tps and patient supprt surfaces prir t use fr sharp edges r splinters caused by damage frm abuse. Replace r repair all defects prir t use. Use f incrrect cleaning chemicals and/r failure t fllw cleaning prcess causing degradatin f materials. Only use apprved chemicals fr cleaning as directed by the Owner s Reference Manual that accmpanied yur prduct. These devices are intended t be used fr many years. Withut prper maintenance and review; fasteners may becme lse and undetected lse fasteners may cause failures f the device. The device shuld be rutinely checked fr cmpleteness, functinality, and all fasteners shuld be checked fr tightness. Prduct Distributin Infrmatin This ntice applies t the apprximately 15,011 OSI Mdular Table System devices Mizuh OSI has distributed ver the eighteen (18) year perid, and that are still currently in use. Mizuh OSI has distributed the apprximately 15,011 devices t apprximately 2,259 custmers wrldwide. T ensure awareness f the recall activity, ur affected custmers (apprximately 2,259) shall be ntified directly f this recall and f ur warnings and recmmendatins. Warning and Recmmendatins: Awareness Requirements relating t awareness, status, functinality and maintenance must be established and practiced at yur facility. Failure t ensure these requirements may cause harm t the patient and/r healthcare staff. If yu require additinal supprt, training and/r assessment f yur device, please cntact Mizuh OSI s Custmer Resurce Grup ( , utside the USA ). Warning and Recmmendatins: Training Mizuh OSI is ntifying all custmers f a ptential f risk fr harm r injury t the patient, healthcare wrker and/r damage t the device if the device is used by untrained persnnel. In additin, Mizuh OSI is ntifying all custmers t ensure that all users f the device are made aware f the Owner s Manual that accmpanied yur prduct device. T ensure a safe experience by bth the healthcare staff and f the patient, all users must be trained at yur facility n prper use, maintenance, and inspectin f the device. If the Owner s Manual prvided with yur device is nt available and/r yu require additinal Owner s Manuals, please cntact Mizuh OSI Custmer Service fr replacements. If yu feel yur staff needs inservice training n the device, please cntact Mizuh OSI s Custmer Resurce Grup t schedule a training class ( , utside the USA ). Page 4 f 6

5 Warning and Recmmendatins: Inspectin Prir t Use Mizuh OSI is ntifying all custmers f a ptential risk if the device has nt been inspected prir t use fr cmpleteness and functinality as described in the Owner s Reference Manual that accmpanied yur prduct device. Failure t perfrm a review prir t use can present a ptential f risk fr harm r injury t the patient, healthcare wrker and/r damage t the device. T ensure a safe experience by bth the healthcare staff and f the patient, each device must be inspected and deemed functinal prir t transferring a patient. These requirements must be established and practiced at yur facility. If yu are unsure f the status f the device, please cntact Mizuh OSI s Custmer Resurce Grup t schedule anther inservice training ( , utside the USA ). Warning and Recmmendatins: Maintenance As a shrt term crrectin, Mizuh OSI is ntifying all custmers f a ptential f risk if the device is nt maintained. A ptential risk f harm r injury t the patient, healthcare wrker and/r damage t the device exists if a device is nt maintained. Therefre, Mizuh OSI is ntifying all custmers f the ptential risk and need fr prper maintenance f the device. Users shuld pay particular attentin t the tightness f all fasteners, review the device fr any defects and/r any malfunctining cmpnent and if fund a repair must be made befre use. T ensure a safe experience by bth the healthcare staff and f the patient, these requirements must be established and practiced at yur facility. Our lng term crrectin is t cntinue t ffer ur full maintenance and warranty prgram and training classes. If yu d nt have a maintenance prgram and/r staff that has been trained n hw t maintain the device, please cntact Mizuh OSI s Custmer Resurce Grup t schedule a review f yur device and/r training class ( , utside the USA ). If yu have any questins cncerning this Crrectin Activity, require servicing r ther related activities, please cntact Keith Lindstrm, Directr f Custmer Resurce Grup fr assistance ( , utside the USA ). Sincerely, Kirke Jayne Directr f Regulatry and Quality Phne: Fax: kjayne@mizuhsi.cm Page 5 f 6

6 URGENT MEDICAL DEVICE CORRECTION Reference: Mizuh OSI Mdular Table Systems (including Mdular Bases, Jacksn Spinal, Imaging, Lateral, & Orthpedic Tps) This frm letter is a simple methd fr yu t use t cmmunicate with Mizuh OSI that yu have received the abve referenced Crrectin activity, reviewed the cntents f the ntificatin, have psted the ntificatin in a prminent area, and cmmunicated this message t all staff and ptential users f this device. Please cmplete this frm by filling in the infrmatin requested belw and fax it t Mizuh OSI at: (FAX N.: ). If yu d nt have access t a fax machine, please return this frm t Mizuh OSI thrugh the regular mail. Mizuh OSI ATTN: Keith Lindstrm, Directr f Custmer Resurce Grup Ahern Avenue Unin City, CA USA If yu have any questins, please cntact Keith Lindstrm, Hspital Name: Custmer Name Reference Number n the Urgent Medical Device Crrectin: ##### Name f persn cmpleting this frm: Title: Date: Page 6 f 6