BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERN

    MDR report key: 2932291 · Received December 7, 2012

    Report

    Report Number
    8010153-2012-00013
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TABLE WAS EVALUATED BY A BERCHTOLD FIELD SERVICE REPRESENTATIVE ON (B)(4) 2012 AT THE LOCATION WHERE THE INCIDENT OCCURRED. ALL THE TABLE FUNCTIONS OPERATED AS EXPECTED WITHOUT PROBLEMS, AND THE REPORTED PROBLEM COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, RN STATED ANESTHESIOLOGIST WAS NOT CONTROLLING TABLE AT THE TIME AND PENDANT WAS ON THE HEAD RAIL OF TABLE. SURGEON NOTED AN UP MOTION ACTIVATION FOR ABOUT THREE SECONDS THEN THE TABLE STOPPED ON IT'S OWN. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERN SURGICAL TABLE GDC BERCHTOLD GMBH & CO. KG D850

    Patients

    Seq Age Sex Outcome Treatment
    1