BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERCHTOLD OPERON

    MDR report key: 3786377 · Received March 28, 2014

    Report

    Report Number
    1220685-2014-00001
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    February 14, 2014
    Report Date
    February 27, 2014
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE WITH A PATIENT ON THE TABLE IN A CHAIR POSITION, BACK UP, LEG DOWN, PARTIAL TREND, IT WAS REPORTED THAT THE LEVEL BUTTON ON THE HAND CONTROL WAS PRESSED AND THE TABLE STARTED TO MOVE INTO TRENDELENBURG. THE TABLE WAS EVALUATED BY A BERCHTOLD FIELD SERVICE REPRESENTATIVE. THE MOVEMENT COULD NOT BE DUPLICATED. TESTING FOUND THE BATTERIES TO BE LOW AND AN INVALID CPU CODE. ALTHOUGH LOW BATTERIES AND THE CPU ERROR COULD NOT BE DIRECTLY ATTRIBUTED TO THE REPORTED PROBLEM, THE BATTERIES AND THE CPU WERE REPLACED AS A PRECAUTIONARY MEASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186303 BERCHTOLD OPERON FQO BERCHTOLD CORP. B810

    Patients

    Seq Age Sex Outcome Treatment
    1