MalfunctionIQZ
FLEXCELL
Received Jul 8, 2022 · Event occurred Apr 30, 2020
Report 3004426795-2022-00002 · MDR key 14960899
Device
Generic name
Prosthetic Battery System
Manufacturer
Infinite Biomedical Technologies LlcModel number
2017200Product problems
- Excessive Heating
- Excessive Heating
Patient
70 YR · Male
- Blister
- Blister
Narrative
Description of Event or Problem
MANUFACTURER RECEIEVED THE COMPLAINT OVER PHONE CALL. THE PROSTHETIST CALLED TO SAY THAT HE HAD A PATIENT USING FLEXCELLS, THE SYSTEM GOT VERY HOT AND STARTED SMOKING. THE PATIENT WAS ABLE TO REMOVE THE SYSTEM BEFORE HE WAS INJURED. IT WAS REPORTED THAT THE PATIENT HAD A SLIGHT BLISTER THAT DID NOT REQUIRE MEDICAL ATTENTION.
Remedial action
- Replace