FDA Adverse Event Malfunction Summary report: N

THERMOPHORE AUTOMATIC HEAT PACK

MDR report key: 3883850 · Received June 13, 2014

Report

Report Number: 1811605-2014-00138
Event Type: Malfunction
Date Received: June 13, 2014
Date of Event: May 16, 2014
Report Date: June 13, 2014
Manufacturer: BATTLE CREEK EQUIPMENT
Product Code: IRT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD, 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 OK, FDA: CORD CUT/BURNED STRAIN RELIEF, CORD OTHER COMMENTS, SWITCH OK, BENT/BROKEN THERMOSTAT, THERMOSTAT DISCOLORATION, CORD BY THE STRAIN RELIEF WAS BENT IN HALF. THE OPPOSITE SIDE OF THE CORD CUT. 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 EVAL OF THE EFFECTIVENESS OF THE SOLUTION.

Description of Event or Problem · 1

CUSTOMER STATED THAT THE SWITCH CAUGHT FIRE AND BURNED THE BLANKET A LITTLE BIT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
351378	THERMOPHORE AUTOMATIC HEAT PACK	ELECTRIC MOIST HEAT PACK	IRT	BATTLE CREEK EQUIPMENT	055

Patients

Seq	Age	Sex	Outcome	Treatment
1