BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE Q7

    MDR report key: 3568075 · Received November 5, 2013

    Report

    Report Number
    2937137-2013-00057
    Event Type
    Malfunction
    Date Received
    November 5, 2013
    Date of Event
    October 21, 2013
    Report Date
    October 21, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUNRISE MEDICAL SENT OUT A REPLACEMENT BACKREST KIT ON (B)(4) 2013, UNDER WARRANTY, TO (B)(6). (B)(6) WILL BE MAKING THE NECESSARY REPAIRS TO THE END USER'S 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

    A MALFUNCTION INVOLVING A QUICKIE Q7 WHEELCHAIR WAS REPORTED TO SUNRISE MEDICAL ON (B)(4) 2013. IT WAS REPORTED TO SUNRISE MEDICAL THAT ONE OF THE BACKREST BRACKETS BROKE. THERE WERE NO FALLS OR INJURIES REPORTED DUE TO THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570726 QUICKIE Q7 WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK