THERMOPHORE
Received Feb 26, 2020
Report 1832415-2020-11124 · MDR key 9757051
Device
Product problems
- Failure to Shut Off
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, "UNIT WILL NOT SHUT OFF AFTER 25 MINS". CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS RETURNED. INVESTIGATOR OBSERVED THAT WHEN THE SWITCH WAS TURNED ON, THE LOW SETTING WOULD NOT REGISTER. THE SWITCH WOULD REGISTER THE MEDIUM SETTING AND THEN TURN OFF IMMEDIATELY. THE INVESTIGATOR INSPECTED THE CONSTRUCTION OF THE PAD AND FOUND NO INDICATION OF FAILURE IN THE PAD, THE SWITCH CASING WAS OPENED WHICH HAD INDICATION OF A POTENTIAL POWER SURGE. THE SWITCH FAILURE COULD NOT BE CONFIRMED AND THE UNIT IS BEING SENT TO VENDOR FOR FURTHER INVESTIGATION OF THE CORD AND SWITCH. SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER VENDOR INVESTIGATION IS COMPLETED.