CATALYST
Received Dec 20, 2024
Report 3005905321-2024-00009 · MDR key 20988767
Device
Generic name
Catalyst 5vx
Manufacturer
Ki MobilityProduct problems
- Mechanical Problem
- Use of Device Problem
- Mechanical Problem
- Use of Device Problem
Patient
NA · Female
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
THE PART WAS RETURNED AND REVIEWED. THE PART APPEARED ADULTERATED. NO DEFECT FOUND. THE USER MANUAL DCN0251 REV 7 STATES TO INSPECT WHEEL LOCK FOR ENGAGEMENT AND FOR ADJUSTMENTS WEEKLY. THE USER MANUAL ALSO STATES CHECK ALL FASTENERS ARE TIGHT ON A MONTHLY BASIS.
Description of Event or Problem
WHEEL LOCK DISEGNAGED DURING PATIENT TRANSFER FROM CHAIR TO BED BECAUSE SOME OF THE BOLTS/HARDWARE WORKED IT'S WAY OUT. BRAKE BOLT WORKED IT'S WAY OUT WHILE HUSBAND WAS TRYING TO MOVE USER FROM CHAIR TO BED. HUSBAND SEATED USER IN CHAIR TO GET A BETTER HOLD OF WHEEL LOCK. THEN WHEEL LOCK DISENGAGED, AND CHAIR ROLLED AWAY.
Additional Manufacturer Narrative
THE WHEELCHAIR COMPONENTS WERE NOT RETURNED YET SO WE COULD DETERMINE IF THE COMPONENTS WERE DEFECTIVE. THIS IS THE INITIAL REPORT AND WE WILL UPDATE WHEN THE PARTS ARE RETURNED AND EVALUATED TO DETERMINE IF THE COMPONENT WAS DEFECTIVE OR IF IT IS A MAINTENANCE ISSUE.
Description of Event or Problem
WHEEL LOCK DISEGNAGED DURING PATIENT TRANSFER FROM CHAIR TO BED BECAUSE SOME OF THE BOLTS/HARDWARE WORKED IT'S WAY OUT. BRAKE BOLT WORKED IT'S WAY OUT WHILE HUSBAND WAS TRYING TO MOVE USER FROM CHAIR TO BED. HUSBAND SEATED USER IN CHAIR TO GET A BETTER HOLD OF WHEEL LOCK. THEN WHEEL LOCK DISENGAGED, AND CHAIR ROLLED AWAY.
Remedial action
- Replace