inforMED
InjuryIRT

THERMOPHORE

Received Mar 11, 2020

Report 1832415-2020-11171 · MDR key 9818288

Device

Generic name

Thermophore

Model number

155

Lot number

000155258173

Product problems

  • Fire
  • Improper or Incorrect Procedure or Method
  • Sparking
  • Material Twisted/Bent

Patient

Not reported

  • Injury
  • Electric Shock
  • Injury
  • Electric Shock

Narrative

Description of Event or Problem

CUSTOMER STATED, "AFTER MIDNIGHT LAYING IN BED, HE WOKE UP TO SPARKS AND FLAMES SHOOTING OUT FROM THE SWITCH. EVERY TIME HE TOUCHED THE SWITCH HE GOT SHOCKED. THE SWITCH WAS GLOWING RED AND NEVER SHUT OFF." CUSTOMER CLAIMED INJURY. PRODUCT WAS RETURNED. THE INVESTIGATOR OBSERVED THAT THE PAD WAS BUNCHED AND THAT THE CORD WAS WRAPPED AND TWISTED. THE SEVERITY OF THE TWISTING OF THE CORD IS THE PROBABLE CAUSE OF THE CUT ON THE CORD NEAR THE SWITCH. THE INVESTIGATOR DETERMINED THAT THE CUT ON THE CORD EXPOSED A WIRE WHICH WOULD CORROBORATE THE CUSTOMER REPORT OF GETTING SHOCKED, SEEING SPARKS AND/OR FLAMES "SHOOTING OUT OF THE SWITCH". THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE CUSTOMER MISUSE OF TWISTING AND WRAPPING THE CORD. THE IFU STATES, "LOOP CORD LOOSELY WHEN STORING. TIGHT WRAPPING MAY DAMAGE CORD AND INTERNAL PARTS."