FDA Adverse Event Malfunction Summary report: N

AUTOPULSE NIMH BATTERY

MDR report key: 2924275 · Received December 14, 2012

Report

Report Number: 3003793491-2012-00350
Event Type: Malfunction
Date Received: December 14, 2012
Date of Event: April 17, 2012
Report Date: April 17, 2012
Manufacturer: ZOLL CIRCULATION, INC.
Product Code: DRM
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

BATTERY SN (B)(4) WAS NOT RETURNED, BUT THE TEST DATA WAS PROVIDED. BASED ON THE TEST DATE, THIS BATTERY WAS NOT MAINTAINED PROPERLY. BATTERY MAINTENANCE PROGRAM LITERATURE INDICATES THAT THE BATTERY IS TO BE CYCLE TESTED AT LEAST ONCE A MONTH. BASED ON MANUFACTURE DATE OF MAY 2009, THIS BATTERY SHOULD HAVE APPROXIMATELY HAD 40 TEST CYCLES; IT HAS ONLY HAD 24. FURTHERMORE, BATTERY MAINTENANCE PROGRAM LITERATURE ALSO INDICATES THAT THE USEFUL LIFE OF EACH AUTOPULSE BATTERY IS BETWEEN 2-4 YEARS. WITHIN THE 2-4 YEAR TIME PERIOD, THE LIFE OF EACH BATTERY IS INFLUENCED BY THE FREQUENCY OF USE AND THE FREQUENCY OF ROUTINE BATTERY MAINTENANCE. BASED ON THE MANUFACTURED DATE (05/2009), THIS BATTERY HAS AGED PAST THE END OF ITS USEFUL LIFE. HOWEVER, BATTERY DATA SHOWED A FULL CHARGE AFTER TEST CYCLE. THEREFORE, THE EXPERIENCED EVENT MAY BE ATTRIBUTED TO NOT PERFORMING DAILY SWAPS AND/OR NOT FULLY CHARGING THE BATTERY BEFORE DEPLOYMENT. NO ADVERSE EVENT REPORTED.

Description of Event or Problem · 1

FOR CCR 9405, IT WAS REPORTED THAT 49 BATTERIES WERE NOT OPERATING CORRECTLY. FOR BATTERY SN (B)(4), REPORTED DESCRIPTION WAS THAT THE BATTERY DID NOT WORK EVEN THOUGH IT WAS FULLY CHARGED. NO ADVERSE EVENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AUTOPULSE NIMH BATTERY	NIMH BATTERY	DRM	ZOLL CIRCULATION, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other