MalfunctionIRT
THERMOPHORE
Received Jan 3, 2020
Report 1832415-2019-10976 · MDR key 9545555
Device
Product problems
- Thermal Decomposition of Device
- Fire
- Sparking
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, " WAS USING THE UNIT AND SUDDENLY SPARKS STARTED SHOOTING OUT FROM THE ON/OFF SWITCH AND THE UNIT CAUGHT FIRE MOMENTARILY." CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS RETURNED. THE INVESTIGATOR OBSERVED A BURN MARK AT THE SWITCH AND EVIDENCE THAT THE USER HAD WRAPPED THE CORD. THE INVESTIGATOR DETERMINED THAT THE WRAPPING OF THE CORD LED TO THE BREAKING OF THE INTERNAL COMPONENTS OF THE SWITCH. THE DAMAGE FROM WRAPPING THE CORD WOULD LEAD TO THE SPARKING AND FIRE REPORTED. THE IFU STATES, "LOOP CORD LOOSELY WHEN STORING. TIGHT WRAPPING MAY DAMAGE CORD AND INTERNAL PARTS."