BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC MOBILITY

    MDR report key: 8816557 · Received July 23, 2019

    Report

    Report Number
    3002905561-2019-00001
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    April 26, 2019
    Report Date
    July 23, 2019
    Manufacturer
    MAGIC MOBILITY
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING OUR INVESTIGATION OF THE FRONTIER S/N (B)(4) IT WAS DETERMINED THAT THE LOOSE WHEEL BOLTS WAS DUE TO HUMAN ERROR DURING THE ASSEMBLY PROCESS. TO THIS DATE (6/21/19), THIS IS THE ONLY REPORTED OCCURENCE OF THIS KIND. THE QUALITY INSPECTION PROCESS HAS BEEN REVISED (EFFECTIVE 5/24/19) TO INSPECT EVERY WHEEL ASSEMBLY PRIOR TO SHIPPING.

    Description of Event or Problem · 1

    THE DEALER FITTED THE CLIENT FOR THE POWER WHEELCHAIR. WHEN CLIENT THEN STARTED TO DRIVE A SHORT DISTANCE IN THEIR HOME ON A TILED SURFACE, IT WAS DISCOVERED THAT THE WHEEL HAD A WOBBLE; THE CLIENT WAS TRANSFERRED OUT OF THE CHAIR. A NUT WAS FOUND ON THE GROUND AND THE DEALER BEGAN AN INVESTIGATION. IT WAS DISCOVERED THAT THE BOLTS IN THE LEFT WHEEL WERE NOT TIGHTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610052 MAGIC MOBILITY FRONTIER ITI MAGIC MOBILITY FRONTIER

    Patients

    Seq Age Sex Outcome Treatment
    1