BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSYSTEM

    MDR report key: 8252270 · Received January 16, 2019

    Report

    Report Number
    8252270
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    December 17, 2018
    Report Date
    January 7, 2019
    Manufacturer
    TRUMPF MEDICAL SYSTEMS, INC. (HILL-ROM, INC.)
    Product Code
    JAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ANESTHESIA STAFF PRESSED THE CONTROL BUTTON TO MOVE THE BED INTO REVERSE TRENDELENBERG POSITION INTRAOPERATIVELY, THE BED MADE A VERY LOUD CRACKING NOISE AND SUDDENLY DROPPED ABOUT AN INCH WITH THE PATIENT ON IT. THE IMMEDIATE AREA WAS INSPECTED, NO OBSTRUCTIONS TO BED MOVEMENT FOUND. THE BED SUBSEQUENTLY RESUMED NORMAL OPERATION. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45177 TRUSYSTEM TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JAE TRUMPF MEDICAL SYSTEMS, INC. (HILL-ROM, INC.) 7000DV 102787453

    Patients

    Seq Age Sex Outcome Treatment
    1