FDA Adverse Event Malfunction Summary report: N

AUTOPULSE® LI-ION BATTERY

MDR report key: 4003782 · Received August 12, 2014

Report

Report Number: 3010617000-2014-00413
Event Type: Malfunction
Date Received: August 12, 2014
Date of Event: July 19, 2014
Report Date: July 22, 2014
Manufacturer: ZOLL CIRCULATION, INC
Product Code: DRM
PMA / PMN Number: K112998
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

CUSTOMER ALSO REPORTED THAT THE AUTOPULSE LI-ION BATTERY DID NOT TAKE A CHARGE IN THE AUTOPULSE MULTI-CHEMISTRY CHARGER (MCC). THE AUTOPULSE BATTERY IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(4) 2014 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

Additional Manufacturer Narrative · 1

INVESTIGATION RESULTS FOR THE RETURNED BATTERY AS FOLLOWS: THE BATTERY ARCHIVES WERE REVIEWED AND ROOT CAUSE WAS INVESTIGATED. THE REPORTED COMPLAINT CAN BE ATTRIBUTED TO RANDOM ERRORS DUE TO NOISE OR ELECTROSTATIC DISCHARGE (ESD) THAT MAY TRIGGER A FAULT IN THE COMMUNICATION BETWEEN THE GAS GAUGE AND THE BATTERY PROCESSOR. IN MOST CASES, THE PROCESSOR IS ABLE TO CORRECT THE FAULT AND THE BATTERY CONTINUES TO FUNCTION NORMALLY. ON RARE OCCASIONS, THE FAULT CANNOT BE CORRECTED AND THE BATTERY CANNOT BE CHARGED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A CODE, THE AUTOPULSE PLATFORM DID NOT POWER ON WITH AN AUTOPULSE LI-ION BATTERY (SERIAL #: (B)(4)). CUSTOMER SWITCHED TO A SPARE BATTERY TO FINISH THE CALL. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
477972	AUTOPULSE® LI-ION BATTERY	LI-ION BATTERY	DRM	ZOLL CIRCULATION, INC	8700-0752-01

Patients

Seq	Age	Sex	Outcome	Treatment
1