BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUMPF TITAN SURGICAL TABLE

    MDR report key: 4080649 · Received August 28, 2014

    Report

    Report Number
    3007143268-2014-00001
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    July 29, 2014
    Report Date
    August 28, 2014
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE KEYPAD OF THE REMOTE HAD A VISIBLE INDENTATION ON THE FLEX BUTTON. THE MOVEMENT REPORTED WAS THE TABLE MOVING INTO THE FLEX POSITION AS IF THE FLEX BUTTON WERE PRESSED. UPON PLUGGING THE REMOTE INTO THE TABLE THE REMOTE CAUSED THE TABLE TO MOVE INTO THE FLEX POSITION DUE TO MECHANICAL DAMAGE OF THE BUTTON. IT SEEMS THAT THE SNAP DISC WAS BROKEN AND LEAD TO PERMANENT OR SPORADIC ELECTRICAL CONDUCT WHICH TRIGGERED THE MOVEMENT. REMOTE WAS REPAIRED. THE HOSPITAL WAS RETRAINED ON HOW TO STOP UNINTENDED MOVEMENT IN THE CASE OF A DAMAGED REMOTE. INVESTIGATION IS ONGOING AT TRUMPF.

    Description of Event or Problem · 1

    A REPORT WAS SENT TO (B)(4) REGARDING A TITAN TABLE THAT MOVED ON ITS OWN. THERE WAS NO PT INJURY REPORTED. THE INCIDENT INVOLVED A DAMAGED REMOTE CONTROL THAT CAUSED THE TABLE TO MOVE INTO A "FLEX POSITION" WITHOUT THE USER PRESSING A BUTTON. THE CASE WAS AT ITS CONCLUSION WHEN THIS OCCURRED AND THE PT WAS MOVED TO A BED TO BE TRANSFERRED OUT OF THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523698 TRUMPF TITAN SURGICAL TABLE TABLE SURGICAL, AC POWERED JEA TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 1228073

    Patients

    Seq Age Sex Outcome Treatment
    1