BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUMPF OP-TISCH TRUSYSTEM 7000DV SURGICAL TABLE

    MDR report key: 12245521 · Received July 28, 2021

    Report

    Report Number
    MW5102841
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    July 2, 2021
    Report Date
    July 27, 2021
    Manufacturer
    TRUMPF MEDICAL SYSTEMS, INC.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT MOVED TO OR TABLE AND HEAD SECTION DISCONNECTED FROM THE REST OF THE TABLE. PATIENT'S UPPER BODY FELL TO THE FLOOR. PATIENT COMPLAINED OF NECK PAIN AND WAS TAKEN TO THE ED, WHERE A CT SCAN DID NOT SHOW ANY FRACTURE. PATIENT DOES CONTINUE TO HAVE NECK PAIN. INVESTIGATION AFTER THE EVENT REVEALED THAT THE HEAD AND FOOT SECTIONS WERE NOT INTERCHANGEABLE, "BGL" NONE OF THE SECTIONS (HAND, MAIN TABLE, OR FOOT) WAS LABELED TO DIRECT STAFF FOR PROPER ORIENTATION OF THE BED SECTIONS. BED SECTIONS IMMEDIATELY LABELED BY SALINA REGIONAL HEALTH CENTER CLINICAL ENGINEERING STAFF. HILL-ROM TRUMPF TECHNICIAN NOTIFIED AT (B)(6). TECHNICIAN REPORTED THAT SECTIONS WERE INTERCHANGEABLE. FIELD AGENT CALLED TO SCHEDULED SERVICE AND HE ALSO REPORTED THAT THE SECTIONS WERE INTERCHANGEABLE. FIELD AGENT ARRIVED AND WAS SURPRISED TO FIND THAT THE HEAD AND FOOT SECTIONS WERE NOT INTERCHANGEABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139132 TRUMPF OP-TISCH TRUSYSTEM 7000DV SURGICAL TABLE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA TRUMPF MEDICAL SYSTEMS, INC. REF 1723633

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other