BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVANCED CONTROL BASE

    MDR report key: 1289603 · Received December 31, 2008

    Report

    Report Number
    2921578-2008-00016
    Event Type
    Other
    Date Received
    December 31, 2008
    Date of Event
    September 24, 2008
    Report Date
    December 3, 2008
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL WAS ALSO INFORMED THAT THEY SHOULD TAKE PRECAUTIONS WHENEVER A PATIENT IS ON THE TABLE AND USE OF THE BELTS WOULD PREVENT PATIENTS FROM BEING DROPPED. ALSO, IT WAS NOTED THAT THE TABLE WAS NOT UNDER OUR PREVENTATIVE MAINTENANCE PROGRAM AND THE TABLE HAD BEEN MAINTAINED BY THEIR SERVICE GROUP. AT THAT TIME, OUR DIRECTOR OF CUSTOMER RESOURCES GROUP AGAIN OFFERED OUR REGULARLY SCHEDULED PREVENTATIVE MAINTENANCE PACKAGE TO ENSURE THE TABLE IS PROPERLY MAINTAINED.

    Description of Event or Problem · 1

    DURING PROCEDURAL ADJUSTMENT OF PATIENT, THE TABLE INADVERTENTLY MOVED 45 DEGREES AND THE UNSECURED PATIENT DROPPED FROM THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED CONTROL BASE OPERATING ROOM TABLE, AC POWERED JEA MIZUHO OSI 5892

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention