BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHEELCHAIR, POWERED

    MDR report key: 8573936 · Received May 1, 2019

    Report

    Report Number
    MW5086343
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    April 26, 2019
    Report Date
    April 29, 2019
    Manufacturer
    MAGIC MOBILITY
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED FOR DELIVERY OF HIS PERMANENT POWER WHEELCHAIR (MAGIC MOBILITY FRONTIER V6). THE ACTUATOR FOR POWER LEG REST ELEVATION WAS UNABLE TO MANAGE THE PT'S LEG INTO ELEVATION WHEN THE CHAIR WAS IN TILT. DURING DRIVE TRAINING, A NUT WAS FOUND ON THE FLOOR UNDER THE CHAIR (THE NYLON THREAD APPEARED TO BE UNBROKEN), AND THE WHEEL WAS WOBBLING. DURING FURTHER INSPECTION, ONE OF THE WHEEL BOLTS IN THE LEFT DRIVE TIRE WAS UNBOLTED AND CAME LOSE WHEN PULLED. THE OTHER TWO BOLTS WERE ALSO LOOSE (THEY WERE ONLY FINGER-TIGHT). ADDITIONALLY, A SPARE DRIVE TIRE WAS PURCHASED, BUT IT WAS NOT INSTALLED ON THE RIM PROPERLY AND WAS NOT FUNCTIONAL. THE CHAIR WAS SENT BACK WITH THE VENDOR FOR RETURN TO THE MFR. VIDEO WAS ALSO CAPTURE OF THE WOBBLING DRIVE WHEEL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360978 WHEELCHAIR, POWERED WHEELCHAIR, POWERED ITI MAGIC MOBILITY FRONTIER V6

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention