BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERCHTOLD

    MDR report key: 2830312 · Received November 6, 2012

    Report

    Report Number
    MW5027561
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BERCHTOLD CORPORATION
    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

    BERCHTOLD OPERON D850 UNINTENTIONAL MOTION. PT GURNEY WAS IMPROPERLY PLACED UNDER SIDE RAIL OF BERCHTOLD TABLE AND BECAME LODGED UNDERNEATH. PT HAD ALREADY BEEN TRANSFERRED TO GURNEY. MULTIPLE STAFF MEMBERS PRESSED, UNLOCK/LOCK BUTTON SO IT WAS NOT CLEAR IF THE TABLE WAS IN THE PROCESS OF LOCKING/UNLOCKING FROM THE FLOOR DURING THE UNINTENTIONAL MOTION. UNINTENTIONAL MOTION OCCURRED WITH THE TABLE REACHING IT'S FULL BACK UPRIGHT POSITION AND THE TABLE HAND CONTROL INDICATING, SERVICE AND, LIMIT CONDITIONS. TABLE WAS EVALUATED BY BERCHTOLD FIELD SERVICE ENGINEER. FLOOR LOCK SENSOR ERRORS WERE NOTED IN TROUBLE LOG COINCIDING WITH THE UNINTENTIONAL MOTION EVENT. TABLE WAS REMOVED FROM SERVICE AND IS AWAITING ADD'L TESTING BY BERCHTOLD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1