MalfunctionJOS
PED RETURN ELEC
Received Aug 18, 2014
Report 1717344-2014-00725 · MDR key 4058288
Device
Product problems
- Device Operates Differently Than Expected
Patient
UNK
- Burn(s)
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE GROUNDING PAD BURNED A PT. NO OTHER INFO WAS PROVIDED.
Additional Manufacturer Narrative
(B)(4). THE INCIDENT SAMPLE HAS BEEN RECEIVED AND IS UNDER INVESTIGATION. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
(B)(4). EVALUATION OF THE INCIDENT E751025 FOUND IT TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. NO CONDITIONS WERE IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, THE CONCOMITANT FORCETRIAD GENERATOR WAS TESTED AND FOUND TO FUNCTION WITHIN SPECIFICATION.