BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICKIE QM710 POWER WHEELCHAIR

    MDR report key: 6806110 · Received August 18, 2017

    Report

    Report Number
    2937137-2017-00021
    Event Type
    Death
    Date Received
    August 18, 2017
    Date of Event
    October 12, 2015
    Report Date
    August 18, 2017
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    ITI
    UDI-DI
    05022408052363
    PMA / PMN Number
    K083249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    LEGAL COUNSEL NOTIFIED SUNRISE MEDICAL ON (B)(6) 2017. SUNRISE MEDICAL HAS OPENED AN INVESTIGATION OF THIS NEARLY TWO YEAR OLD INCIDENT. AFTER RESEARCHING THE HISTORY OF THIS CHAIR, IT WAS FOUND THAT THERE HAS NEVER BEEN A REPORT OF AN INCIDENT OF ANY TYPE TO SUNRISE MEDICAL IN REFERENCE TO THIS WHEELCHAIR. IT WAS ALSO FOUND THAT THERE HAS NEVER BEEN ANY REQUESTS FOR REPLACEMENT/SERVICE PARTS FOR THIS WHEELCHAIR. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) SUNRISE MEDICAL (US) LLC RECEIVED A COURT SUMMONS FROM THE LAW OFFICES OF (B)(6). STATING THE FOLLOWING: THE END USER'S MOTHER WAS ASSISTING THE END USER TO EXIT THEIR VAN VIA THE LIFT. THE MOTHER STATED THAT WHILE DOING SO, ONE OF THE WHEELS BECAME LODGED BETWEEN THE VAN'S INTERIOR FLOOR. SHE POWERED OFF THE WHEELCHAIR'S CONTROLLER/JOY STICK, ATTEMPTED TO FREE THE WHEEL, AND AFTER DOING SO, TURNED THE WHEELCHAIR'S CONTROLLER BACK ON. WHEN THE WHEELCHAIR WAS POWERED BACK ON, THE WHEELCHAIR ALLEGEDLY IMMEDIATELY ACCELERATED FORWARD TO THE END OF THE CHAIR LIFT, WHICH WAS STILL RAISED ABOVE THE GROUND, OVER THE CHAIR LIFT'S SAFETY GATE, WHICH WAS IN PLACE AND ON TO THE PAVEMENT BELOW. ALLEGEDLY THE END USER'S HEAD SLAMMED INTO THE PAVEMENT AND BECAME TRAPPED UNDER THE WEIGHT OF THE WHEELCHAIR. IT IS ALSO ALLEGED THAT THE END USER WAS DIAGNOSED WITH AN INTRACRANIAL HEMORRHAGE AND DIED FROM HIS INJURIES ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585567 QUICKIE QM710 POWER WHEELCHAIR POWER WHEELCHAIR ITI SUNRISE MEDICAL (US) LLC EIPW11 05022408052363

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Death