BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERCHTOLD

    MDR report key: 2831940 · Received November 7, 2012

    Report

    Report Number
    MW5027581
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BERCHTOLD
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    UNINTENTIONAL TABLE UP MOTION. RN STATED ANESTHESIOLOGIST WAS NOT CONTROLLING TABLE AT THE TIME AND PENDANT WAS ON THE HEAD RAIL OF TABLE. SPOKE TO ANESTHESIOLOGIST AND SURGEON ABOUT THE TABLE MALFUNCTION. BOTH STATED THE PENDANT WAS ON THE TABLE RAIL. ANESTHESIOLOGIST HAD HIS BACK TURNED TO THE TABLE. SURGEON NOTED AN UP MOTION ACTIVATION FOR ABOUT THREE SECONDS THEN THE TABLE STOPPED ON ITS OWN. BIOMED NOTICED PENDANT DOWN BUTTON REQUIRES A HARD PRESS BEYOND IT'S DETENT TO ACTIVATE THE DOWN FUNCTION. BIOMED NOT SURE IF THIS IS RELATED TO THE TABLE MALFUNCTION - I.E. NUMEROUS KEY COMMANDS AT ONE TIME. BIOMED WAS NOT ABLE TO RECREATE THE UNINTENTIONAL UP MOTION. BIOMED CONTACTED (B)(4) TO REVIEW TABLE AND PENDANT. TABLE REMOVED FROM SERVICE AND UNDER EVAL BY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BERCHTOLD SURGICAL TABLE GDC BERCHTOLD OPERON D850

    Patients

    Seq Age Sex Outcome Treatment
    1