Name: Oxygen Care Ltd Address: 2 Holfeld Business Park, Kilmacanogue, Co. Wicklow, Ireland URGENT FIELD SAFETY NOTICE - UPDATE

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1 Carefusion UK Jays Close The Crescent Basingstoke RG22 4BS United Kingdom Name: Oxygen Care Ltd Address: 2 Holfeld Business Park, Kilmacanogue, Co. Wicklow, Ireland URGENT FIELD SAFETY NOTICE - UPDATE Product Name: AVEA ventilators Product Reference: All AVEA models Serial Numbers: All (See attached list in Appendix 2) FSCA Identifier: RES2013-AVEA-01 Date: 7 th October 2013 Type of Action: Field Safety Notice Dear Mr/Mrs I write following my letter dated 18 th September 2013 to inform you that the Field Safety Notice issued by CareFusion has been updated. Please find below the changes highlighted in green. Product Name: AVEA ventilator all models CareFusion has identified a potential risk associated with AVEA ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error. The published volume accuracy specification of the neonatal hotwire flow sensor is +/- 1ml + 10%. PROBLEM AND AFFECTED DEVICES ISSUE: AVEA ventilators may experience the underreporting of tidal volume if used in conjunction with the neonatal hotwire flow sensor, CareFusion part number This error is due to the barometric pressure sensor compensation. Clinically significant changes in barometric pressure are generally seen at altitudes greater than 5,000 feet above sea level (ASL). While all AVEA ventilators fall under this voluntary Field Safety Corrective Action, hospitals in locations at high elevations (higher than 1524 meters or 5000 feet above sea level) that are using the AVEA ventilator in the neonatal patient care setting are at greatest risk of this error. Single patient use VarFlex sensors are not affected by this corrective action and will compensate for changes to atmospheric barometric pressure. The adult and pediatric patient setting are not affected by this issue.

2 POTENTIAL RISK: In cases where a patient is ventilated at an altitude of equal or greater than 1,524 meters ASL the ventilator may under report the delivery of tidal volume. The degree of which is based upon the altitude at the location of use. For reference: The measurement error at 1,220 meters ASL (approximately 681 mmhg) would be less than 10% and the error at 1,829 meters ASL would be approximately 16-19%. ACTIONS TO BE TAKEN BY CAREFUSION: CareFusion has initiated a project to develop a new version of software that will resolve this issue. ACTION TO BE TAKEN BY THE CUSTOMER CareFusion does not require the return of your devices. Once this software is available it must be installed on all AVEA ventilators. If the location of your AVEA ventilator(s) is above 1,524 meters ASL, and you are using the AVEA in the neonatal patient setting, customers are asked to take one of the following actions. o AVEA Comprehensive: Continue the use of your AVEA Comprehensive ventilator with the use of a VarFlex single patient use flow sensor, CareFusion part number (10 pack). o AVEA Standard: Discontinue the use of your AVEA Standard ventilator in the neonatal patient setting. If the location of your hospital is located at altitude above 1,524 meters ASL a customer support representative will contact you to arrange for a suitable alternative if necessary. If the location of your hospital is below 1,524 meters, or the ventilator is exclusively used in the adult and/or pediatric patient setting, no action is necessary other than to perform the necessary software update when made available. Please promptly return the enclosed response card (Appendix 2) to expedite the correction process and acknowledge receipt of this notification. The US Food and Drug Administration (FDA) has been notified of this action. Please use the chart provided below for questions and support. CareFusion Contact Contact Information Areas of Support CareFusion Technical Recall Related Support Support.CC.EU@carefusion.com Questions CareFusion Business Partner Oxygen Care Ltd 2 Holfeld Business Park, Kilmacanogue, Co. Wicklow, Ireland Recall Related Questions Please promptly return the enclosed Response Card to expedite the correction process and acknowledge receipt of this Notification. We appreciate your cooperation and we recognize the inconvenience this may cause your facility. Thank you for your support on this important matter.

3 Sincerely, Mirela Boureanu CareFusion QRA Manager UK and Ireland Enclosed: List of affected units, customer response card

4 Appendix 1: List of affected part and serial numbers PART NUMBER CONFIGURATION BASE MODEL SHIP DATE TO OXYGEN CARE LTD CLEAN SN PN SN AVEA COMP CONF 10/09/2003 ADV ADV AVEA COMP 27/11/2002 ACV01721 ACECACV AVEA STD 22/04/2003 ADV01605 ASHOADV AVEA STD 22/04/2003 ADV01624 ASHOADV AVEA STD 22/04/2003 ADV01648 ASHOADV AVEA STD 22/04/2003 ADV01653 ASHOADV AVEA STD 22/04/2003 ADV01669 ASHOADV AVEA COMP 23/04/2003 ADV01718 ACECADV AVEA COMP 16/12/2003 ADV ADV AVEA COMP 16/12/2003 ADV ADV AVEA COMP 16/12/2003 ADV ADV06113 R AVEA STD W/COMP CONFIG 20/05/2005 ADV06218 R172ADV AVEA COMP 15/10/2004 AEV AEV AVEA COMP 08/10/2004 AEV AEV AVEA COMP 08/10/2004 AEV AEV AVEA COMP 08/10/2004 AEV AEV AVEA COMP 15/10/2004 AEV AEV AVEA COMP 08/10/2004 AEV AEV AVEA COMP 08/10/2004 AEV AEV AVEA COMP 08/10/2004 AEV AEV AVEA COMP 08/10/2004 AEV AEV AVEA PLUS 08/12/2005 AFV AFV AVEA PLUS 08/12/2005 AFV AFV AVEA PLUS 08/12/2005 AFV AFV AVEA PLUS 08/12/2005 AFV AFV AVEA STD 25/11/2009 AKV AKV AVEA COMP 25/11/2009 AKV AKV AVEA COMP 25/11/2009 AKV AKV AVEA COMP 25/11/2009 AKV AKV AVEA COMP 25/11/2009 AKV AKV AVEA COMP 25/11/2009 AKV AKV AVEA COMP 25/11/2009 AKV AKV AVEA COMP 25/11/2009 AKV AKV AVEA STD 25/11/2009 AKV AKV AVEA STD 25/11/2009 AKV AKV04423 Page 4 of 7

5 AVEA STD 25/11/2009 AKV AKV AVEA STD 25/11/2009 AKV AKV AVEA STD 25/11/2009 AKV AKV AVEA STD 25/11/2009 AKV AKV AVEA STD 25/11/2009 AKV AKV AVEA STD 01/04/2010 BAV BAV AVEA STD 01/04/2010 BAV BAV AVEA STD 01/04/2010 BAV BAV04250 Page 5 of 7

6 Appendix 2 Business Partner Response Card UPDATE - FIELD SAFETY NOTICE AVEA Ventilators Acknowledgment and Verification Form Product Name: Product Reference: FSCA Identifier: AVEA ventilators All AVEA models RES2013-AVEA-01 Name of Business Partner Organization Business Partner Address Name of Business Partner Correspondent Telephone number address Signature Date I have read and understand the contents of this Field Safety Notice and confirm that all affected medical equipment within my area of responsibility has been checked, and Software will be upgraded as required. I have completed the enclosed table to reflect those devices, that cannot be upgraded (not found or scrapped). Page 6 of 7

7 Equipment Country Distribution Table: Model Number Serial Number Affected and will be done Other (not found or scrapped) Note: If more space is needed for the above table please attach a separate document. Please return this form to: Miss Mirela Boureanu Address: Carefusion UK, Jays Close, The Crescent, Basingstoke, RG22 4BS or By mirela.boureanu@carefusion.com (Return of your product is not necessary) For further questions please call CareFusion Technical Support Page 7 of 7