BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYST 4

    MDR report key: 16775797 · Received April 20, 2023

    Report

    Report Number
    3005905321-2023-00002
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    January 27, 2023
    Report Date
    April 10, 2023
    Manufacturer
    KI MOBILITY, LLC
    Product Code
    IOR
    UDI-DI
    00850013379019
    PMA / PMN Number
    K062660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE RESIDUAL RISK IDENTIFIED IN THE RISK ASSESSMENT PERFORMED ON THIS MODEL AND FAILURE MODE. IF THE FAILURE WERE TO REOCCUR, IT COULD RESULT IN MORE SERIOUS INJURY TO A USER.

    Description of Event or Problem · 0

    A COMPLAINT WAS REPORTED ON (B)(6) 2023 STATING THAT THE DEALER CLAIMS THE RIGHT CASTER CAME OFF OF THE CHAIR DURING PROPULSION. THE END USER FELL DOWN WITH THE CHAIR AND SUFFERED MILD BRUISING AND PAIN. IT WAS FURTHER REPORTED THAT IT WAS THE RIGHT SIDE CASTER HOUSING BOLT AND ECCENTRIC NUT THAT HAD FELL OUT. "THE BOTTOM NUT (ECCENTRIC NUT?) AND BOLT ON THE CASTER ASSEMBLY FELL OFF AND CAUSED THE CASTER TO PIVOT AND THE CHAIR TIPPED OVER WITH THE PATIENT STILL IN THE CHAIR." NO FURTHER INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206760 CATALYST 4 MECHANICAL WHEELCHAIR IOR KI MOBILITY, LLC 4 00850013379019

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown