BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPPIE ZONE

    MDR report key: 3657764 · Received November 14, 2013

    Report

    Report Number
    2937137-2013-00061
    Event Type
    Malfunction
    Date Received
    November 14, 2013
    Date of Event
    November 8, 2013
    Report Date
    November 8, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    IOR
    PMA / PMN Number
    K973673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE NOT BEING RETURNED TO SUNRISE MEDICAL (US) LLC. WE WILL MAKE EVERY EFFORT TO COMPLETE AN INVESTIGATION THROUGH EITHER OBTAINING PICTURES OR VIDEO OF THE CHAIR INVOLVED, OR BY PERFORMING AN INVESTIGATION ON A CHAIR OF EQUIVALENT CONSTRUCTION. IF AND WHEN MORE INFORMATION CAN BE OBTAINED FROM THAT INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A MALFUNCTION INVOLVING A ZIPPIE ZONE WAS REPORTED TO SUNRISE MEDICAL ON (B)(4) 2013. THE DEALER REPORTED THAT THE BACKREST BRACKETS GAVE OUT. THE DEALER REPORTED THAT THE END USER HAD FALLEN OUT OF THE CHAIR BUT THAT THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591953 ZIPPIE ZONE WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC. EIRZ1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK