BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYST 5

    MDR report key: 16545846 · Received March 15, 2023

    Report

    Report Number
    3005905321-2023-00001
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 17, 2023
    Report Date
    March 15, 2023
    Manufacturer
    KI MOBILITY, LLC
    Product Code
    IOR
    UDI-DI
    00850013379026
    PMA / PMN Number
    K062660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. BASED ON THE INFORMATION PROVIDED, PROPER MAINTENANCE WAS NOT CARRIED OUT IN ACCORDANCE WITH THE IFU AND WAS LIKELY THE CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    A COMPLAINT WAS REPORTED TO KI MOBILITY ON (B)(6) 2023 STATING THAT A RIGHT SIDE NUT FOR THE CASTER HOUSING FELL OUT WHILE THE END USER WAS TRAVELING OVER A THRESHOLD IN THE ASSISTED LIVING FACILITY THE END USER LIVES AT. THE COMPLAINT RECEIVED STATED THE FOLLOWING, "END USER IS VERY ACTIVE AND HITS THRESHOLDS PRETTY HARD IN THE HOME THEY LIVE IN. THE END USER HIT THE THRESHOLD GOING INTO THE RESTROOM AND THE BOLT FELL OUT CAUSING THE CASTER HOUSING TO BREAK LOOSE. THE END USER FELL TO THE FLOOR. WAS SEEN BY A DOCTOR AND IS OKAY WITH ONLY A BUMP AND A BRUISE. THE FACILITY SAYS THEY HAVE NOT PROVIDED THE CHAIR MAINTENANCE TO CHECK TO SEE HOW LONG THE SCREWS HAVE BEEN LOOSE. THE INCIDENT TOOK PLACE IN AN ASSISTED LIVING HOME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037553 CATALYST 5 MECHANICAL WHEELCHAIR IOR KI MOBILITY, LLC CATALYST 5 00850013379026

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other