FDA Adverse Event Malfunction Summary report: N

THERMOPHORE AUTOMATIC HEAT PACK

MDR report key: 3823757 · Received May 2, 2014

Report

Report Number: 1811605-2014-00111
Event Type: Malfunction
Date Received: May 2, 2014
Date of Event: April 21, 2014
Report Date: May 1, 2014
Manufacturer: BATTLE CREEK EQUIPMENT
Product Code: IRT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

OUR INSPECTION FOUND A SMALL CUT IN THE CORD NEAR THE SWITCH THAT COULD HAVE EXPOSED THE USER TO BARE WIRE. THE INSPECTION ALSO REVEALED CUSTOMER MISUSE AS OUR INSPECTION FOUND: POLY COVER DIRTY OR STAINED, FDA: CORD CUT/BURNED STRAIN RELIEF, SWITCH OK, PAD BUNCHED, BENT/BROKEN LEAD, BENT/BROKEN THERMOSTAT, PAD DIRTY OR STAINED. THIS TELLS US THAT THE PAD WAS NOT BEING PROPERLY USED AS PER OUR INSTRUCTIONS IN THE MANUAL. CORD BREAKAGE USUALLY OCCURS WHEN THE CORD IS REPEATEDLY OVER BENT NEAR THE SWITCH. WE HAVE INITIATED A CAPA PROJECT (B)(4) TO REDUCE THE OCCURRENCE OF THIS ISSUE. A NEW JACKETED CORD DESIGN WAS LAUNCHED IN PRODUCTION ON 03/10/2014 THAT CLOSES (B)(4) PENDING A FUTURE EVALUATION OF THE EFFECTIVENESS OF THE SOLUTION.

Description of Event or Problem · 1

CUSTOMER MAILED THE PAD TO US.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
264077	THERMOPHORE AUTOMATIC HEAT PACK	ELECTRIC MOIST HEAT PACK	IRT	BATTLE CREEK EQUIPMENT	055

Patients

Seq	Age	Sex	Outcome	Treatment
1