FOCUS
Received Mar 17, 2025
Report 3005905321-2025-00002 · MDR key 21618031
Device
Product problems
- Use of Device Problem
- Human-Device Interface Problem
- Use of Device Problem
- Human-Device Interface Problem
Patient
NA · Unknown
- Laceration(s)
- Laceration(s)
Narrative
Additional Manufacturer Narrative
THE COMPONENT RETURNED HAD SIGNIFICANT WEAR ON THE WHEEL LOCK FROM WHAT APPEARED TO BE SEVERE RUBBING ON THE TIRE. THE METAL FACE OF THE WHEEL LOCK INTERFACING WITH THE TIRE WAS SIGNIFICANTLY WORN AWAY. WHEEL LOCKS ARE NOT TO BE USED AS BRAKES TO SLOW OR STOP THE WHEELCHAIR. SEE USER MANUAL DCN0255 REV 6. NO PROOF OF REQUIRED MAINTENANCE WAS FOUND.
Description of Event or Problem
IT WAS STATED THE LEFT WHEEL LOCK WOULD NOT HOLD AND ENGAGE. THE USER WAS GOING TO TRANSFER FROM BED TO THE CHAIR AND WHEN HE WENT TO ENGAGE WHEEL LOCK. THE WHEEL LOCK SLIPPED, THE USER FELL FORWARD HITTING HIS HEAD ON A DRESSER CAUSING HIM TO CUT HIS HEAD AND REQUIRED STITCHES.
Remedial action
- Replace