BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUMPF TRULIGHT ALC+ CEILING MOUNTED

    MDR report key: 3976783 · Received May 21, 2014

    Report

    Report Number
    9681407-2014-00001
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 15, 2014
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO.KG
    Product Code
    FSY
    PMA / PMN Number
    K102758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POINT OF DETACHMENT IS SECURED BY A SNAP RING. THE SNAP RING WAS NOT LOCATED UPON THE ARRIVAL OF THE TRUMPF TECHNICIAN THAT DAY (ROOM HAD BEEN CLEANED). TRUMPF MEDICAL SYSTEMS, INC. INSTALLED THE EQUIPMENT AT THE USER FACILITY. TRUMPF TECHNICIAN INSPECTED SIMILAR DEVICES AT THIS USER FACILITY AND DETERMINED THAT THE REQUIRED HARDWARE WAS PROPERLY INSTALLED ON THOSE DEVICES AT THE TIME OF INSPECTION. THE DEVICE WAS INSTALLED APPROXIMATELY 2 WEEKS PRIOR TO THE FAILURE. DEVICE IS DESIGNED SUCH THAT IN THE ABSENCE OF THE SNAP RING THE ARM SHOULD NOT BE ABLE TO FALL UNLESS A USER IS MOVING THE LIGHT TO ITS HIGHEST POSITION (REMOVING THE WEIGHT FROM THE END OF THE SPRING ARM). THEREFORE, IF A SNAP RING IS NOT PRESENT OR SHOULD BECOME DISLODGED, THE DEVICE WOULD NOT BE EXPECTED TO FALL UNLESS A USER IS HOLDING ONTO IT. INVESTIGATION INDICATES THAT MOST LIKELY CAUSE WAS THAT THE SNAP RING WAS NOT INSTALLED DURING ASSEMBLY OF THE PRODUCT.

    Description of Event or Problem · 1

    A TRULIGHT ALC+ CEILING MOUNTED LIGHT HEAD AND SPRING ARM BECAME DETACHED FROM THE CENTRAL AXIS (HORIZONTAL TOP ARM) AND FELL. THE HOSPITAL TECHNICIAN WAS MOVING THE LIGHT INTO POSITION WHEN THE LIGHT HEAD AND SPRING ARM FELL. THE HOSPITAL TECHNICIAN WAS STRUCK BY THE LIGHT HEAD IN THE HEAD. THE LIGHT HEAD THEN FELL TO THE FLOOR. NO PATIENT INJURY WAS REPORTED. THE HOSPITAL TECHNICIAN REPORTED A BUMP ON THE HEAD AND HEADACHE. NOTE THE SURGERY IN PROGRESS WAS ON THE PATIENT'S HAND AND NOT AN "OPEN" CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302769 TRUMPF TRULIGHT ALC+ CEILING MOUNTED LIGHT SURGICAL, CEILING MOUNTED FSY TRUMPF MEDIZIN SYSTEME GMBH + CO.KG 1574851

    Patients

    Seq Age Sex Outcome Treatment
    1