FLEXCELL
Received Jul 8, 2022 · Event occurred Apr 22, 2020
Report 3004426795-2022-00001 · MDR key 14960964
Device
Generic name
Prosthetic Battery System
Manufacturer
Infinite Biomedical Technologies LlcModel number
2017200Product problems
- Charging Problem
Patient
45 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ACCORDING TO THE PROSTHETIST, THE BATTERY HAD BEEN FULLY CHARGED AND WAS IN USE WHEN IT SUDDENLY STOPPED WORKING. THE PATIENT ATTEMPTED TO JUMP IT OR REBOOT IT WITHOUT SUCCESS. THE PATIENT THEN PLUGGED THE SOCKET INTO THE CAR CHARGER. IT WAS EXTREMELY HOT AND SMELLED LIKE IT WAS MELTING WHILE UNPLUGGING THE CAR CHARGER. THE PATIENT ATTEMPTED TO CHARGE THE SOCKET AGAIN AT HOME WITH NO SUCCESS. DURING THE EVENT, NO INJURIES WERE REPORTED.
Additional Manufacturer Narrative
THE DETAILS ON PATIENT INFORMATION ARE PENDING AND WILL BE PROVIDED ONCE THE PRACTITIONER RESPONDS TO MANUFACTURER. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: THE DETAILS ON COMPONENTS USED IN PROSTHESIS ARE PENDING AND WILL BE PROVIDED ONCE THE PRACTITIONER RESPONDS TO THE MANUFACTURER.
Remedial action
- Replace