BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE 2 LITE

    MDR report key: 3327268 · Received August 19, 2013

    Report

    Report Number
    2937137-2013-00031
    Event Type
    Malfunction
    Date Received
    August 19, 2013
    Date of Event
    July 20, 2013
    Report Date
    July 23, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K072153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEALER REPORTED TO SUNRISE MEDICAL (US) LLC THAT A LOANER WHEELCHAIR WAS ISSUED TO THE END USER UNTIL THE END USER'S WHEELCHAIR IS REPAIRED BY UNITED SEATING & MOBILITY. SUNRISE MEDICAL HAS SENT UNITED SEATING AND MOBILITY A REPLACEMENT REAR SIDE FRAME THAT IS BEING COVERED UNDER WARRANTY. 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 F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PER DEALER, REPORTED TO SUNRISE MEDICAL (US) LLC THAT ON (B)(6) 2013 THE END USER FELL OUT OF THIS WHEELCHAIR. THE DEALER REPORTED THAT THE REAR SIDE FRAME BROKE WHICH CAUSED THE END USER TO FALL BACKWARD OUT OF HIS CHAIR. THE END USER IS ALLEGING INJURY TO HIS HEAD, RIGHT ARM AND LOWER BACK. THE DEALER REPORTED THAT NONE OF THE INJURIES ARE SERIOUS, BUT THAT THE END USER WAS ADMITTED TO THE HOSPITAL FOR PRECAUTIONARY REASONS DUE TO THE END USER BEING ON BLOOD THINNERS. THE END USER WAS RELEASED FROM THE HOSPITAL THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401052 QUICKIE 2 LITE WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC EIQ2N

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization