BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON

    MDR report key: 4444690 · Received September 25, 2014

    Report

    Report Number
    4444690
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 25, 2014
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    TOWARD THE END OF SURGICAL PROCEDURE, WHILE TRYING TO POSITION THE BED AS PER PHYSICIAN INSTRUCTION, THE BED BEGAN TO FLEX ON ITS OWN AND WAS UNABLE TO BE STOPPED. THE TECHNICIAN WAS IMMEDIATELY CALLED TO GIVE ASSISTANCE. HE PROCEEDED TO TRY TO CHANGE POSITION MANUALLY, BUT IT WOULD NOT MOVE. BOTH SURGEONS WERE AWARE OF THE SITUATION AS IT WAS HAPPENING. PROCEDURE WAS COMPLETED AND BLANKETS WERE PUT UNDER LEGS AND TORSO TO TRY TO MAINTAIN A BETTER ALIGNMENT. THE PT WAS IMMEDIATELY MOVED TO THE STRETCHER FOR TRANSPORT. AFTER THE SURGERY ENDED AND AFTER THE PATIENT WAS OFF THE TABLE IT WAS NOTED THAT THERE WAS FLUID FROM THE BED ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599559 OPERON TABLE, OPERATING-ROOM, ELECTRICAL FQO BERCHTOLD CORP. B810 *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR