BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON

    MDR report key: 1919343 · Received November 22, 2010

    Report

    Report Number
    8010153-2010-00001
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 13, 2010
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TABLE WAS EVALUATED BY A BERCHTOLD CORP SERVICE TECH ON (B)(4) 2010 AFTER THE INCIDENT AT LOCATION WHERE THE INCIDENT OCCURRED. THE TABLE IS IN GOOD PHYSICAL CONDITION. ALL THE TABLE FUNCTIONS OPERATED AS EXPECTED WITHOUT PROBLEMS, AND THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE TABLE WILL BE RETURNED TO THE (B)(4).

    Description of Event or Problem · 1

    THE TABLE WAS IN SLIGHT TILT LEFT AND REV-TREND. THE RETURN TO LEVEL BUTTON WAS PUSHED, AND THE TABLE PROPERLY RETURNED TO LEVEL FROM THE TILT LEFT POSITION. AFTER THE TILT LEFT RETURN, IT WAS REPORTED THAT THE TABLE SHIMMIED, AND THEN IMMEDIATELY WENT ALL THE WAY DOWN INTO THE REVERSE TRENDELENBURG POSITION UNTIL THE FOOT SECTION CONTACTED THE FLOOR. THE PATIENT SLID ABOUT A FOOT DOWN THE TABLE BUT DID NOT FALL OFF. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1