BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE IRIS 2

    MDR report key: 2932300 · Received January 24, 2013

    Report

    Report Number
    2937137-2013-00001
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 15, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LL.
    Product Code
    IOR
    PMA / PMN Number
    K952641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 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

    THE DEALER REPORTED THAT THE CASTERS SNAPPED WHERE THE SPOKE AND HUB ARE LOCATED WHILE THE MOTHER AND CAREGIVER ATTEMPTED TO TURN THE CHAIR IN THE VAN TO PUSH THE CLIENT DOWN THE RAMP. THE MOTHER AND CAREGIVER DID NOT REALIZE THE CASTERS WERE BROKEN AND AFTER PUSHING THE CLIENT DOWN THE RAMP AND ATTEMPTING TO ENTER THE HOME, THE CLIENT FELL OUT OF THE CHAIR AND BROKE HER ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34751 QUICKIE IRIS 2 WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LL. EIZ4-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention