inforMED
MalfunctionIRT

THERMOPHORE

Received Feb 26, 2020

Report 1832415-2020-11126 · MDR key 9759481

Device

Generic name

Thermophore

Lot number

061420

Product problems

  • Device Emits Odor
  • 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, "SMELLED RUBBER BURNING, THEN SAW THE CORD SPARK." CUSTOMER DID NOT CLAIM INJURY. PRODUCT HAS NOT BEEN RETURNED. WITHOUT PRODUCT RETURNED THE CAUSE OF THE FAILURE CAN NOT BE DETERMINED. AN INVESTIGATION INTO THE PROVIDED LOT NUMBER FROM THE CUSTOMER FOUND NO OTHER ISSUES WITHIN THE LOT. AN INVESTIGATION INTO SIMILAR FEEDBACKS FOR SPARKING FOUND THAT THE PRIMARY CAUSE OF OTHER REPORTED ISSUES WERE CUSTOMER MISUSE OF TWISTING/ WRAPPING THE CORD. THE IFU STATES, "LOOP CORD LOOSELY WHEN STORING. TIGHT WRAPPING MAY DAMAGE CORD AND INTERNAL PARTS." ONCE PRODUCT IS RETURNED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.