BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEEL CHAIR, WITH ELECTRIC SEAT LIFT, ELECTRIC RECLINE, AND ELECTRIC LEG

    MDR report key: 7999561 · Received October 23, 2018

    Report

    Report Number
    MW5080772
    Event Type
    Injury
    Date Received
    October 23, 2018
    Date of Event
    September 8, 2018
    Report Date
    October 21, 2018
    Manufacturer
    SUNRISE MEDICAL PTY LTD.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUNRISE MEDICAL PTY LTD WHEEL CHAIR BRANDED MAGIC MOBILITY FRONTIER V6 COMPACT 73. PURCHASED (B)(6) 2017, (B)(6). THIS POWERED WHEEL CHAIR IS EXPORTED TO THE USA. WITHOUT WARNING, WHILST BEING OPERATED IN AN AGE CARE NURSING HOME, A MAIN DRIVE WHEEL (THERE ARE TWO MID-CHAIR DRIVE WHEELS) FELL OFF DUE TO PRODUCT MFG AND DESIGN DEFECTS (AS EXPLAINED BY AUTHORIZED SERVICE AGENT OF SUNRISE MEDICAL). THIS INCIDENT CAUSED THE WHEELCHAIR TO CRASH INTO A WALL, AS ONE WHEEL WAS STILL DRIVING THE CHAIR. PHOTOGRAPH TAKEN BY NURSING STAFF AND AN INCIDENT REPORT ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838744 POWERED WHEEL CHAIR, WITH ELECTRIC SEAT LIFT, ELECTRIC RECLINE, AND ELECTRIC LEG POWERED WHEELCHAIR ITI SUNRISE MEDICAL PTY LTD. FRONTIER V6 COMPACT 73

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| R