BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE

    MDR report key: 970722 · Received December 28, 2007

    Report

    Report Number
    2937137-2007-00019
    Event Type
    Malfunction
    Date Received
    December 28, 2007
    Date of Event
    November 29, 2007
    Report Date
    November 28, 2007
    Manufacturer
    SUNRISE MEDICAL INC.
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN NO PARTS RELATED TO THIS CHAIR THAT HAVE BEEN RETURNED TO THE MANUFACTURER AS OF THIS DATE.

    Description of Event or Problem · 1

    SUNRISE SALE'S REP RECEIVED A CALL FROM THE END-USER'S SON THAT A BOLT IN THE BACK BROKE CAUSING HIS FATHER TO FALL OUT OF THE CHAIR. THE END-USER WAS TAKEN TO EMERGENCY FOR PRECAUTIONARY MEASURES. THERE WAS NO INJURY TO THE END-USER AND HE WAS RELEASED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKIE WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL INC. QUICKIE GTX P/N EIF3

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization