BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE Q7

    MDR report key: 3457806 · Received October 9, 2013

    Report

    Report Number
    2937137-2013-00048
    Event Type
    Malfunction
    Date Received
    October 9, 2013
    Date of Event
    September 20, 2013
    Report Date
    September 20, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUNRISE MEDICAL SENT SOUTHWEST MEDICAL A REPLACEMENT BACKREST KIT ON (B)(4) 2013. SOUTHWEST MEDICAL WILL BE MAKING THE NECESSARY REPAIRS TO THE WHEELCHAIR. 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 CALLED SUNRISE MEDICAL ON (B)(6) 2013 TO REPORT A MALFUNCTION INVOLVING A QUICKE Q7 WHEELCHAIR. THE DEALER ALLEGES THAT THE END USER WAS LENDING BACK IN HIS WHEELCHAIR WHEN THE FOLDING BACKREST SNAPPED. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514353 QUICKIE Q7 WHEELCHAIR, MECHINCAL IOR SUNRISE MEDICAL (US) LLC. EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1