BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPPIE IRIS

    MDR report key: 3284197 · Received August 2, 2013

    Report

    Report Number
    2937137-2013-00027
    Event Type
    Malfunction
    Date Received
    August 2, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    IOR
    PMA / PMN Number
    K973673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    DEALER REPORTED TO SUNRISE MEDICAL THAT THE LEFT SIDE BASE FRAME BROKE WHERE THE CASTER AND FORK ASSEMBLY MOUNT INSIDE THE CASTER FRAME HOUSING. DEALER STATED THAT THE END USER'S FAMILY DOESN'T KNOW HOW THE BASE FRAME BROKE APART. NO FALL OR INJURIES WERE REPORTED TO SUNRISE MEDICAL BY THE DEALER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364090 ZIPPIE IRIS WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC. EIZ5A

    Patients

    Seq Age Sex Outcome Treatment
    1