BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPPIE VOYAGE

    MDR report key: 3574091 · Received November 8, 2013

    Report

    Report Number
    9616084-2013-00009
    Event Type
    Malfunction
    Date Received
    November 8, 2013
    Date of Event
    October 24, 2013
    Report Date
    October 24, 2013
    Manufacturer
    SUNRISE MEDICAL
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUNRISE MEDICAL SENT OUT A REPLACEMENT ZIPPIE VOYAGE STROLLER TO (B)(6) ON (B)(6) 2013 AS A WARRANTY REPLACEMENT TO THE DEFECTIVE UNIT. 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

    IT WAS REPORTED TO SUNRISE MEDICAL THAT ON (B)(6) 2013 A MALFUNCTION INVOLVING A ZIPPIE VOYAGE STROLLER HAD OCCURRED. THE DEALER REPORTED TO SUNRISE MEDICAL THAT THE STROLLER SEAT FRAME HAD FALLEN OUT OF THE BASE FRAME TWICE. THERE WERE NO INJURIES INVOLVED DUE TO THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579145 ZIPPIE VOYAGE CHARI WITH CASTERS INM SUNRISE MEDICAL EIZ14

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO