BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE GT

    MDR report key: 3871694 · Received April 17, 2014

    Report

    Report Number
    2937137-2014-00013
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE'RE STILL TRYING TO COORDINATE WITH THE DEALER THE RETURN OF THE PARTS INVOLVED IN THIS INCIDENT. THE DEALER DOESN'T KNOW IF THE END-USER STILL HAS THE PARTS. IT APPEAR THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE NOT BEING RETURNED TO SUNRISE MEDICAL (US) LLC. WE WILL MAKE EVERY EFFORT TO COMPLETE AN INVESTIGATION THROUGH EITHER OBTAINING PICTURES OR VIDEO OF THE CHAIR INVOLVED, OR BY PERFORMING AN INVESTIGATION ON A CHAIR OF EQUIVALENT CONSTRUCTION. IF AND WHEN MORE INFO CAN BE OBTAINED FROM THAT INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A MALFUNCTION INVOLVING A QUICKIE GT WHEELCHAIR WAS REPORTED TO SUNRISE MEDICAL ON (B)(6) 2014. THE DEALER REPORTED THAT THE END-USER WAS RIDING IN HIS WHEELCHAIR OVER A THRESHOLD INTO HIS HOME WHEN THE CAMBER TUBE BROKE IN HALF. AS A RESULT, BOTH OF THE REAR WHEELS CAME OFF AND THE FRAME COLLAPSED INTO HIS RIBS. THE DEALER REPORTED THAT THE END-USER WAS A LITTLE SORE AFTER THE INCIDENT BUT THAT THERE WAS NO SERIOUS INJURY SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236572 QUICKIE GT WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC. EIR3

    Patients

    Seq Age Sex Outcome Treatment
    1