MalfunctionIOR
ROGUE
Received Jan 20, 2016 · Event occurred Jan 9, 2016
Report 3005905321-2016-01656 · MDR key 5380968
Device
Product problems
- Break
- Component Falling
Patient
36 YR
- Fall
- Head Injury
- Fall
- Head Injury
Narrative
Additional Manufacturer Narrative
WHEELCHAIR WILL BE RETURNED TO MANUFACTURER FOR EVALUATION TO DETERMINE THE CAUSE OF EVENT.
Description of Event or Problem
CUSTOMER CLAIMS THAT THE BACKREST BOLT SNAPPED WHERE THE POST CONNECTS TO THE SEAT CAUSING THE BACK TO FALL WHILE GOING DOWN A RAMP. END USER FELL INJURING HIS HEAD AND WAS HOSPITALIZED FOR A FEW DAYS, THE EXTENT OF THE INJURY HAS NOT BEEN COMMUNICATED BUT USER WAS RELEASED.
Remedial action
- Replace
- Repair