BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS 60" TRANSFER CARRIAGE

    MDR report key: 1021215 · Received March 28, 2008

    Report

    Report Number
    2515984-2008-00005
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 28, 2008
    Manufacturer
    STERIS CORPORATION - MEXICO
    Product Code
    FLE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    UPON NOTIFICATION OF THE ISSUE, A STERIS TECHNICIAN WAS DISPATCHED TO THE ACCOUNT TO INSPECT THE 60" ATLAS LOADING CAR AND TRANSFER CART TO HINGED PLATFORM. A NEW WHEEL WAS INSTALLED AND WELL TIGHTENED IN PLACE. THE UNIT WAS MANUFACTURED ON Y2006 BEFORE THE IMPLEMENTATION OF THE CORRECTIVE ACTIONS IN MANUFACTURING PLANT ON FEB 2008. CORRECTIVE ACTIONS IMPLEMENTED INCLUDING: MANUFACTURER STOCK AND IN PROCESS MATERIAL WERE INSPECTED WITH NO DEFECTS FOUND. DEFINE WHEEL ASSEMBLY TORQUE REQUIREMENTS. UPDATE DEVICE HISTORY RECORD TO RECORD TORQUE ACTIVITY. MARCH EACH WHEEL WHEN THE TORQUE ACTIVITY IS COMPLETED ACCORDING TO THE TRAVELER.

    Description of Event or Problem · 1

    THE LEFT REAR WHEEL OF THE TRANSFER CARD (ATLAS 60" TRANSFER CART) FELL OFF. THE OPERATOR TRIED TO STOP THE CART AND SUSTAINED BURNS TO THE ARMS. THERE WERE NO WITNESSES TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS 60" TRANSFER CARRIAGE TRANSFER CARRIAGE FLE STERIS CORPORATION - MEXICO 4011084 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization