inforMED
MalfunctionIRT

THERMOPHORE

Received Oct 7, 2017

Report 1832415-2017-06057 · MDR key 6927680

Device

Generic name

Thermophore

Model number

255

Lot number

2550816

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.