MalfunctionIRT
THERMOPHORE AUTOMATIC HEAT PACK
Received Sep 30, 2013 · Event occurred Aug 22, 2013
Report 1811605-2013-00127 · MDR key 3557086
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
THE USER MAILED US THE PAD BECAUSE IT STOPPED WORKING.
Additional Manufacturer Narrative
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 THE PAD WAS VERY BUNCHED UP, CORD WAS TANGLED AND LEADS WERE OUT OF PLACE. 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.