inforMED
MalfunctionIRT

THERMOPHORE

Received Dec 23, 2019

Report 1832415-2019-10947 · MDR key 9511440

Device

Generic name

Thermophore

Model number

155

Lot number

00155305195

Product problems

  • Overheating of Device
  • 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, "PAD GETS VERY HOT. TOO HOT AND HAVE TO SHUT OFF, IN USE I MAYBE SIT ON THE PAD WHEN USED ON BACK" CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS RETURNED. THE INVESTIGATOR CONDUCTED TESTING FOR MAXIMUM TEMPERATURES, POSSIBILITIES OF HOT SPOTS, AND WATTAGE DRAW OF THE DEVICE. THE INVESTIGATION SUPPORTED THAT THE UNIT WAS WITHIN SPECIFICATION AND NO DEFECTS WERE OBSERVED. CUSTOMER ADMITTED TO SITTING ON THE PRODUCT DURING USE. IFU STATES, "DO NOT SIT ON, LIE ON, OR CRUSH PAD. AVOID SHARP FOLDS". NO DEFECTS OBSERVED.