AED Recalls

Alert Details for #2005040270 (Released 4/25/2005 12:54 EDT)
Description:	Update to RASMAS alerts #2005020361 of 2/28/05 and 2005030080 of 3/2/05 (additional product). Certain Monophasic LIFEPAK 500 Automated External Defibrillators
Manufacturer:	Medtronic, Inc., Redmond, WA
Reason:	The affected AEDs may continue to display a connect electrodes message and may not analyze the patient's heart rhythm even when the electrodes are properly connected. Failure to analyze the patient's heart rhythm will inhibit defibrillation, if it is needed.
Analyst Comments:	Please click on the hyperlinked 'Source' in the Links field to open and read the attached pdf file. This file includes complete details of this recall. The company has already completed the updates or upgrades to the devices originally identified as affected. The company plans to complete the update or upgrade to the additional affected devices by May 31, 2005. Affected AEDs may remain in service, and customers with devices in this additional group are currently being contacted with recommendations for use and replacement schedules. Only certain monophasic LIFEPAK 500 AEDs manufactured in 1997 are included in this action. Customers with further questions about this issue should call 1-877-873-7630 or visit www.medtronic-ers.com/500 to determine if their device is included in the action.

Alert Type:	Recall URGENT	Source Alert Type:	Class I
Domain:	Biomedical Devices	Source Type:	Food and Drug Administration
Distribution:	Worldwide	Source Date:	4/25/2005

Links:
	http://www.medtronic-ers.com/500/Affected_Devices_Serial_Number_List.pdf Attachment: AED2005040270.pdf

Product Information

Product Description	Model/Product Number	Stock Identifiers	Volume	Recall ID
Certain Monophasic LIFEPAK 500 Automated External Defibrillators, manufactured in 1997.	Not specified	Serial #s listed in URL/Attachment	396 units added to recall of 2/25/05.	Not specified