MalfunctionIRT
THERMOPHORE
Received Mar 18, 2020
Report 1832415-2020-11221 · MDR key 9850760
Device
Product problems
- Device Emits Odor
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, "SMELLS LIKE BURNING WIRE." CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS RETURNED. FUNCTIONAL TESTING WAS PERFORMED ON THE UNIT AND THE INVESTIGATOR INSPECTED INDIVIDUAL COMPONENTS. NO INDICATION OF BURNING WAS EVIDENT. HOWEVER, TO THE CUSTOMER CLAIM OF "SMELLS LIKE BURNING WIRE" THERE WAS A SMELL CAUSED BY THE START-UP HEATING OF THE UNIT NATIVE TO THE LEAD OF THE PAD. THERE WAS NO EVIDENCE THAT ANY COMPONENT OF THE BAD INDICATED MALFUNCTION OR BURNING. THE PRODUCT FUNCTIONED AS INTENDED.