THERMOPHORE AUTOMATIC HEAT PACK
Received Mar 24, 2014 · Event occurred Feb 13, 2014
Report 1811605-2014-00056 · MDR key 3784575
Product problems
- Sparking
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER CALLED AND STATED THAT THE PAD SPARKED.
Additional Manufacturer Narrative
OUR EXAMINATION REVEALED THAT ONE OF THE TERMINALS HAD BEEN BROKEN NEAR A THERMOSTAT, WHICH HAD COMPROMISED OUR DOUBLE-INSULATED DESIGN. WE ALSO FOUND SEVERAL OTHER INTERNAL COMPONENTS THAT WERE DAMAGED, INDICATING THAT THE CUSTOMER MISUSED THE PAD BY APPLYING AN EXCESSIVE, LOCALIZED FORCE ON OR NEAR THE THERMOSTAT TERMINAL. WE CONCLUDED THAT THIS REPORT WAS ATTRIBUTABLE TO MISUSE BY THE USER, AND FAILURE TO FOLLOW INSTRUCTIONS AS TO THE CARE AND HANDLING OF THE UNIT. ALL THERMOSTATS WERE DISCOLORED AND BENT OR BROKEN. SEVERAL OF THE LEADS WERE BENT OR BROKEN IN HALF AND OUT OF PLACE. PAD WAS BUNCHED UP. ALTHOUGH WARNING LABELS AND INSTRUCTION BOOKLETS WARN AGAINST SITTING OR LAYING ON THE PRODUCT, WE HAVE A CORRECTIVE ACTION PROJECT (B)(4) UNDERWAY TO MAKE THE DESIGN MORE ROBUST.