CATALYST 5VX
Received Jul 11, 2024 · Event occurred Apr 8, 2024
Report 3005905321-2024-00003 · MDR key 19724676
Device
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
NA · Male
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Description of Event or Problem
END USER STATED THEY LOST THE HARDWARE FOR THE CASTER HOUSING AND PERFORMED HOME REPAIR. END USER DID NOT NOTIFY DEALER OF PROBLEM. IT IS UNKNOWN HOW LONG THE WHEELCHAIR WAS IN USE BEFORE CASTER FELL OFF. IT'S UNKNOWN AS TO WHETHER PROPER MAINTENANCE WAS PERFORMED.
Additional Manufacturer Narrative
IT WAS REPORTED THAT END USER PERFORMED DIY ON THE WHEELCHAIR AFTER THE INITIAL FAILURE WITHOUT GETTING THE WHEELCHAIR PROPERLY INSPECTED AND REPAIRED. WE HAVE NOT BEEN ABLE TO CONFIRM WHETHER MAINTENANCE, REQUIRED IN THE IFU, WAS PERFORMED. USER INSTRUCTION MANUAL (DCN0251.3) STATES TO CHECK ALL FASTENERS ARE TIGHT ON A MONTHLY BASIS. INVESTIGATION CLOSED. ATTEMPTED 5 TIMES TO GATHER MORE INFORMATION AND NO RESPONSE.
Additional Manufacturer Narrative
STILL UNDER INVESTIGATION. IT WAS REPORTED THAT END USER PERFORMED DIY ON THE WHEELCHAIR AFTER THE INITIAL FAILURE WITHOUT GETTING THE WHEELCHAIR PROPERLY INSPECTED AND REPAIRED. WE HAVE NOT BEEN ABLE TO CONFIRM WHETHER MAINTENANCE, REQUIRED IN THE IFU WAS PERFORMED. USER INSTRUCTION MANUAL (DCN0251.3) STATES TO CHECK ALL FASTENERS ARE TIGHT ON A MONTHLY BASIS. WILL FILE ADDTIONAL INFORMATION IF IT BECOMES AVAILABLE.
Description of Event or Problem
END USER STATED THEY LOST THE HARDWARE FOR THE CASTER HOUSING AND PERFORMED HOME REPAIR. END USER DID NOT NOTIFY DEALER OF PROBLEM. IT IS UNKNOWN HOW LONG THE WHEELCHAIR WAS IN USE BEFORE CASTER FELL OFF. IT'S UNKNOWN AS TO WHETHER PROPER MAINTENANCE WAS PERFORMED.
Remedial action
- Replace