FDA Adverse Event Malfunction Summary report: N

AUTOPULSE NIMH BATTERY

MDR report key: 2963066 · Received January 25, 2013

Report

Report Number: 3003793491-2012-00349
Event Type: Malfunction
Date Received: January 25, 2013
Date of Event: June 14, 2012
Report Date: June 14, 2012
Manufacturer: ZOLL CIRCULATION INC
Product Code: DRM
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ALTHOUGH THE BATTERIES SN (B)(4) WERE NOT RETURNED, THE AUTOPULSE ARCHIVE FILES INDICATED THAT PROPER BATTERY MGMT PROCEDURES, (DAILY SYSTEM CHECKS AND BATTERY SWAPS) HAD NOT BEEN PERFORMED. ARCHIVE FILES ALSO REVEALED MULTIPLE USER ADVISORY 3 (ERROR COMMUNICATING WITH BATTERY CONTROLLER) AND USER ADVISORY 44 (BATTERY VOLTAGE TOO LOW DURING COMPRESSION). THESE ERRORS INDICATE THAT BATTERIES WITH LOW VOLTAGE WERE USED. THEREFORE, THE REPORTED EVENT WAS MOST LIKELY DUE TO THE CUSTOMER NOT FOLLOWING BATTERY MGMT PROCEDURES. NO ADVERSE EVENT REPORTED.

Description of Event or Problem · 1

CUSTOMER REPORTED THAT WHILE ON A FULL ARREST THE UNIT WAS TURNED ON AND DELIVERED ONLY A FEW COMPRESSIONS AND DISPLAYED A CHANGE BATTERY MESSAGE. A NEW BATTERY WAS PUT IN THE UNIT WITH THE SAME RESULT. CUSTOMER ALSO INDICATED THAT HE WAS UNSURE ABOUT WHEN THE BATTERIES WERE PLACED IN THE UNIT. CUSTOMER PLACED A THIRD BATTERY IN THE UNIT AND OPERATED IT USING A CPR DUMMY WITH NO ISSUES REPORTED. THIS REPORT PERTAINS TO BATTERY #2 (NOT RETURNED) THAT WAS USED DURING THE REPORTED INCIDENT. REPORTS #3003793491-2012-00154 AND #3003793491-2012-00155 WERE SUBMITTED FOR THE AUTOPULSE PLATFORM AND BATTERY #1 THAT WAS ASSOCIATED WITH THIS REPORT. NO ADVERSE EVENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
36071	AUTOPULSE NIMH BATTERY	CARDIAC NIMH BATTERY	DRM	ZOLL CIRCULATION INC

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other