MalfunctionIQZ
MYOENERGY INTEGRAL
Received Apr 15, 2016 · Event occurred Mar 21, 2016
Report 9615892-2016-00006 · MDR key 5580346
Device
Generic name
Battery Pack
Manufacturer
Otto Bock Healthcare Products GmbhModel number
757B35=0Lot number
0012 2016 02
Product problems
- Fire
- Battery Problem
- Fire
- Battery Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CAUSE OF THE MALFUNCTION IS A DEFECTIVE ELECTRONIC COMPONENT OF THE BATTERY CHARGER.
Description of Event or Problem
THE MYO ENERGY INTEGRAL BATTERY WAS CONNECTED TO THE CHARGER BY THE CPO PRIOR TO THE FITTING OF AN EXTERNAL UPPER LIMB PROSTHESIS. AFTER ABOUT TWO (2) HOURS OF CHARGING THE BATTERY INFLAMED. THE FIRE WAS DISCOVERED IMMEDIATELY BY AN EMPLOYEE AROUND AND COULD BE EXTINGUISHED. NO CONSEQUENCES OR IMPACT TO PATIENT OR OTHER PERSONS.