BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE GT

    MDR report key: 3624282 · Received December 9, 2013

    Report

    Report Number
    2937137-2013-00067
    Event Type
    Malfunction
    Date Received
    December 9, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 22, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE BEING RETURNED TO SUNRISE MEDICAL (US) LLC. IF AND WHEN THE CHAIR/PARTS ARE RECEIVED, OUR INTERNAL FAILURE INVESTIGATOR WILL COMPLETE THE INVESTIGATION AND A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A MALFUNCTION INVOLVING A QUICKIE GT WAS REPORTED TO SUNRISE MEDICAL ON (B)(6) 2013. THE DEALER REPORTED THAT THE END USER WAS IN HER WHEELCHAIR GOING UP A RAMP INTO HER VAN WHEN THE LEFT ANTI-TIP RECEIVER SNAPPED. THERE WERE NO REPORTS OF A FALL OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639038 QUICKIE GT WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC EIR3

    Patients

    Seq Age Sex Outcome Treatment
    1