FDA Adverse Event Malfunction Summary report: N

AUTOPULSE LI-ION BATTERY

MDR report key: 3174697 · Received May 23, 2013

Report

Report Number: 3003793491-2013-00595
Event Type: Malfunction
Date Received: May 23, 2013
Date of Event: November 26, 2012
Report Date: November 26, 2012
Manufacturer: ZOLL CIRCULATION, INC.
Product Code: DRM
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE AUTOPULSE LI-ION BATTERY INVOLVED IN THE EVENT WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2012 AND WAS ANALYZED. ARCHIVE ANALYSIS FOR THE RETURNED LI-ION BATTERY REVEALED THAT THE BATTERY WAS LEFT IN THE AUTOPULSE PLATFORM FOR APPROXIMATELY 12 DAYS. THE PROBABLE ROOT CAUSE ATTRIBUTED TO THE CUSTOMER'S REPORTED COMPLAINT MAY HAVE BEEN DUE TO USER ERROR OR MISUSE. FOR INSTANCE THE USER LEFT THE LI-ION BATTERY IN THE AUTOPULSE PLATFORM FOR AN EXTENDED PERIOD OF TIME AND DID NOT FOLLOW THE INSTRUCTIONS FOR CHARGING, BATTERY ROTATION AND THE USE OF THE BATTERY STATUS BUTTON. THE AUTOPULSE POWER SYSTEM GUIDE (12457-001) AND THE LI-ION BATTERY INSERT (12546-001) STATE THE FOLLOWING "CAUTION: IT IS STRONGLY RECOMMENDED THAT A BATTERY NOT BE STORED IN AUTOPULSE WHEN AUTOPULSE IS NOT ACTIVE SERVICE (SHIFT DEPLOYMENT) OR IS IN EXTENDED STORAGE. STORAGE IN AUTOPULSE LONGER THAN A WEEK MAY RESULT IN IRREVERSIBLE DAMAGE TO THE BATTERY." STN NUMBER K112998.

Description of Event or Problem · 1

IT WAS REPORTED THAT A LI-ION BATTERY FAULTED. FAULT LIGHT WAS UNABLE TO BE CLEARED. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO ADDITIONAL DETAILS WERE PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
228355	AUTOPULSE LI-ION BATTERY	AUTOPULSE LI-ION BATTERY	DRM	ZOLL CIRCULATION, INC.	8700-0752-01	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1