MalfunctionIRT
THERMOPHORE
Received Oct 7, 2017
Report 1832415-2017-06057 · MDR key 6927680
Device
Product problems
- Inappropriate/Inadequate Shock/Stimulation
- Sparking
Patient
Not reported
- Shock from Patient Lead(s)
- Shock from Patient Lead(s)
Narrative
Description of Event or Problem
CUSTOMER STATED "FEELS SPARKS AND SHOCKS WITHIN THE PAD WHEN IT'S ON AND EVEN WHEN IT'S OFF FOR A LITTLE BIT." PRODUCT WAS RETURNED FOR INVESTIGATION. AN INVESTIGATION WAS DONE INTO THE CUSTOMERS COMPLAINT, AND UPON INVESTIGATION THE INSPECTOR COULD NOT FIND ANY DEFECT WITH THE PRODUCT. THE PAD WAS TESTED ON THREE SEPARATE OCCASIONS BY A QUALITY CONTROL TECHNICIAN, AND ON ALL THREE OCCASIONS THE PAD WAS HEATING AND FUNCTIONING PROPERLY. BASED ON THE BCE REVIEW OF FEEDBACKS, BCE DID NOT OBSERVE A SIMILAR ISSUE WITHIN THE LOT.