THERMOPHORE
Received Jan 22, 2020
Report 1832415-2019-11020 · MDR key 9616554
Device
Product problems
- Fire
- Improper or Incorrect Procedure or Method
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER STATED, " THE PAD CAUGHT FIRE BY THE WIRES LEADING INTO THE SWITCH." CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS NOT RETURNED. AN INVESTIGATION INTO THE MANUFACTURED LOT FOUND NO OTHER INSTANCES OF POTENTIAL FIRES OCCURRING FROM THIS LOT. AN INVESTIGATION INTO RETURNED PRODUCTS FOR PAD FIRE FOUND THAT FIRE WAS PRIMARILY CAUSED BY CUSTOMER MISUSE OF TWISTING/ WRAPPING THE CORD TO TIGHT OR FOLDING/ LAYING ON THE PAD. THE IFU STATES, "LOOP CORD LOOSELY WHEN STORING. TIGHT WRAPPING MAY DAMAGE CORD AND INTERNAL PARTS.", "DO NOT SIT ON, LIE ON, OR CRUSH PAD. AVOID SHARP FOLDS". FURTHER INVESTIGATION WILL BE CONDUCTED ONCE THE PRODUCT IS RETURNED, ALONG WITH A SUPPLEMENTAL REPORT SUBMITTED.