BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYST 5VX

    MDR report key: 19724676 · Received July 11, 2024

    Report

    Report Number
    3005905321-2024-00003
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    April 8, 2024
    Report Date
    June 27, 2024
    Manufacturer
    KI MOBILITY
    Product Code
    IOR
    UDI-DI
    00850013379033
    PMA / PMN Number
    K062660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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 · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385234 CATALYST 5VX 5VX IOR KI MOBILITY CATALYST 5VX 00850013379033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other