BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPPIE VOYAGE

    MDR report key: 3750912 · Received November 4, 2013

    Report

    Report Number
    9616084-2013-00008
    Event Type
    Malfunction
    Date Received
    November 4, 2013
    Date of Event
    October 18, 2013
    Report Date
    October 21, 2013
    Manufacturer
    SUNRISE MEDICAL
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS REPORTED TO SUNRISE MEDICAL VIA EMAIL BY THE END USER'S FATHER. SUNRISE MEDICAL HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE INITIAL REPORTER TO OBTAIN MORE INFORMATION ON THE ALLEGED MALFUNCTION. 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 FOR 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 VOYAGE STROLLER WAS REPORTED TO SUNRISE MEDICAL ON (B)(6)2013. THE MALFUNCTION WAS REPORTED VIA EMAIL FROM THE END USER'S FATHER. IT WAS REPORTED TO SUNRISE MEDICAL THAT ON TWO OCCASIONS THE SEAT FRAME FELL REARWARD WHILE THE CHILD WAS STRAPPED IN TO THE STROLLER. THERE WERE NO FALLS OR INJURIES REPORTED DUE TO THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567750 ZIPPIE VOYAGE CHAIR WITH CASTER INM SUNRISE MEDICAL EIZ14

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK