BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE Q7

    MDR report key: 3284198 · Received August 2, 2013

    Report

    Report Number
    2937137-2013-00026
    Event Type
    Malfunction
    Date Received
    August 2, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    IOR
    PMA / PMN Number
    K973673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    DEALER REPORTED TO SUNRISE MEDICAL THAT THE END USER WAS SITTING IN HER CHAIR WHEN THE BACK REST BOLTS SHEARED OFF. THE END USER DIDN'T FALL OUT OF HER CHAIR AND THERE WERE NO INJURIES REPORTED TO SUNRISE MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364318 QUICKIE Q7 WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC. EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1