MalfunctionIRT
THERMOPHORE
Received Mar 23, 2020
Report 1832415-2020-11244 · MDR key 9865236
Device
Product problems
- Overheating of Device
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER STATED, " PAD IS SLOW COMING ON, THEN THE PAD GETS EXTREMELY HOT." CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS NOT RETURNED. PRODUCT HAS NOT BEEN RETURNED. INVESTIGATION INTO SIMILAR REPORTED ISSUES FOUND THE PRODUCT(S) FUNCTIONED AS INTENDED. THE CLAIM OF "EXTREMELY HOT" WAS NOT SUPPORTED WITH TESTING, WITH THE PREVIOUSLY RETURNED PRODUCTS FOUND WITHIN SPECIFICATION. ONCE PRODUCT IS RETURNED THE INVESTIGATION WILL BE CONDUCTED AND SUPPLEMENTAL REPORT WILL BE SUBMITTED.