BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPPIE VOYAGE

    MDR report key: 3558176 · Received October 28, 2013

    Report

    Report Number
    9616084-2013-00007
    Event Type
    Malfunction
    Date Received
    October 28, 2013
    Date of Event
    October 3, 2013
    Report Date
    October 3, 2013
    Manufacturer
    SUNRISE MEDICAL
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    A MALFUNCTION INVOLVING A ZIPPIE VOYAGE STROLLER WAS REPORTED TO SUNRISE MEDICAL ON (B)(6) 2013. IT WAS REPORTED THAT THE LATCHES THAT HOLD THE SEAT FRAME TO THE BASE HAD SNAPPED CAUSING THE END USER TO FALL OUT OF THE STROLLER. THERE WERE NO INJURIES REPORTED DUE TO THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552736 ZIPPIE VOYAGE CHAIR WITH CASTERS INM SUNRISE MEDICAL EIZ14

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO