BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON

    MDR report key: 2843846 · Received October 26, 2012

    Report

    Report Number
    8010153-2012-00009
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 5, 2012
    Report Date
    October 25, 2012
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    FWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TABLE WAS EVALUATED BY A BERCHTOLD FIELD SERVICE REPRESENTATIVE ON (B)(4) 2012. THE PROBLEMS COULD NOT BE DUPLICATED WHEN USING THE ORIGINAL HAND CONTROL, THE REPLACEMENT HAND CONTROL, AND THE SERVICE PROGRAM. THE ORIGINAL HAND CONTROL EXHIBITED SIGNS OF DAMAGE, WAS REPLACED, AND WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE WITH A PATIENT ON THE TABLE, THE TABLE WAS REPORTED TO HAVE MOVED INTO TILT AND UNLOCKED WITH NO ACTIVATION OF THE HAND CONTROL. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1