inforMED
MalfunctionIRT

THERMOPHORE

Received Jan 3, 2020

Report 1832415-2019-10976 · MDR key 9545555

Device

Generic name

Thermophore

Model number

155

Lot number

00155133193

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."