BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMSCO ATLAS 60" TRANSFER CARRIAGE

    MDR report key: 981576 · Received January 17, 2008

    Report

    Report Number
    2515984-2008-00001
    Event Type
    Injury
    Date Received
    January 17, 2008
    Date of Event
    December 15, 2007
    Report Date
    January 16, 2007
    Manufacturer
    STERIS CORPORATION - ERIE
    Product Code
    FLE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON NOTIFICATION OF THE ISSUE, A STERIS TECHNICIAN WAS DISPATCHED TO THE ACCOUNT TO INSPECT THE 60" TRANSFER CARRIAGE. A NEW WHEEL WAS INSTALLED AND THE OTHER WHEELS WERE INSPECTED AND FOUND TO BE TIGHT. IT APPEARS THE WHEEL CAME LOOSE DUE TO IMPROPER TIGHTENING AT ASSEMBLY. MANUFACTURER STOCK AND IN PROCESS MATERIAL WERE INSPECTED WITH NO DEFECTS FOUND. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED INCLUDING: DEFINE WHEEL ASSEMBLY TORQUE REQUIREMENTS. UPDATE DEVICE HISTORY RECORD TO RECORD TORQUE ACTIVITY. MARK EACH WHEEL WHEN THE TORQUE ACTIVITY IS COMPLETED ACCORDING TO THE TRAVELER.

    Description of Event or Problem · 1

    AFTER PULLING LOADING CART OUT OF STERILIZER ONTO TRANSFER CARRIAGE (AMSCO ATLAS 60" TRANSFER CARRIAGE), THE OPERATOR PUSHED BACK (HANDLED END) OF TRANSFER CARRIAGE TO THE LEFT PERPENDICULAR OF THE STERILIZER. THAT IS WHEN LOADING CART AND TRANSFER CARRIAGE TIPPED OVER AND RIGHT REAR SWIVEL WHEEL FELL OUT OF THE FRAMING CAUSING THE OPERATOR TO SPRAIN THEIR BACK. THERE WERE NO WITNESSES TO THIS INCIDENT. THE OPERATOR WAS SENT TO THE EMERGENCY ROOM FOR EVALUATION AND ASSIGNED TO LIGHT DUTY FOR ONE WEEK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization