BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMSCO

    MDR report key: 2250759 · Received September 8, 2011

    Report

    Report Number
    2250759
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    June 24, 2011
    Report Date
    September 8, 2011
    Manufacturer
    STERIS
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CONTROLLER AND MANUAL CONTROLLER OF THE OR TABLE DOES NOT WORK. RESPONDED TO SERVICE CALL, AFTER TROUBLE SHOOTING THE UNIT, FOUND MICRO SWITCH FOR THE FLOOR LOCK WAS DAMAGED BEYOND REPAIR. THE WORKORDER IS CURRENLY OPEN UNTIL RESOLUTION IS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMSCO OR BED HAND CONTROL FQO STERIS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR