MalfunctionIRT
THERMOPHORE
Received Mar 6, 2020
Report 1832415-2020-11159 · MDR key 9801822
Device
Product problems
- Failure to Shut Off
Patient
Not reported
- Injury
- Injury
Narrative
Description of Event or Problem
CUSTOMER STATED, "UNIT WILL NOT SHUT OFF". CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS RETURNED. THE UNIT WAS TESTED FOR FUNCTION AND WAS DETERMINED TO HAVE NO CONTINUITY IN THE SWITCH. THE LIGHT ON THE SWITCH FUNCTIONED, BUT WOULD NOT TURN OFF. THE SWITCH FUNCTION OF THE UNIT COULD NOT OPERATE AS THERE WAS NO CONTINUITY TO THE PAD. THE DETERMINED CAUSE OF THE MALFUNCTION IS UNKNOWN AND THE SWITCH WILL BE SENT TO THE MANUFACTURER FOR FURTHER INVESTIGATION. ANY ADDITIONAL INFORMATION FROM THE INVESTIGATION WILL BE SUBMITTED WITH A SUPPLEMENTAL REPORT.