BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKMOVE SIT-TO-STAND

    MDR report key: 8430008 · Received March 18, 2019

    Report

    Report Number
    3009481053-2019-00012
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    February 4, 2019
    Report Date
    November 11, 2019
    Manufacturer
    HANDICARE AB
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    TRACES OF MISUSE WERE IDENTIFIED ON THE DEVICE. RESULTS FROM INTERNAL INVESTIGATION INDICATE THAT THE DEVICE TILTING WAS MOST LIKELY CAUSED BY MISUSE IN COMBINATION WITH LACK OF SERVICE MAINTENANCE. MANUFACTURER SEES NO REASON FOR FURTHER ACTION AT THIS TIME BUT WILL CONTINUE TO MONITOR THIS TYPE OF EVENT.

    Description of Event or Problem · 0

    A STAFF MEMBER WAS ASSISTING A USER TO STAND USING QUICK MOVE STANDING AID DEVICE. THE DEVICE BEGAN TO TILT. THE STAFF MEMBER LOWERED THE USER TO THE GROUND. THE DEVICE WAS REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    A STAFF MEMBER WAS ASSISTING A USER TO STAND USING QUICK MOVE STANDING AID DEVICE. THE USER AND DEVICE BEGAN TO TILT. THE STAFF MEMBER LOWERED THE USER TO THE GROUND. THE DEVICE WAS REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220888 QUICKMOVE SIT-TO-STAND TRANSFER AID IKX HANDICARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1