BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUMPF ILED 7

    MDR report key: 19529193 · Received June 12, 2024

    Report

    Report Number
    MW5156220
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    June 8, 2023
    Report Date
    June 7, 2024
    Manufacturer
    TRUMPF/BAXTER MEDICAL SYSTEMS GMBH + CO. KG
    Product Code
    FSS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE CLEANING OR IN BETWEEN SURGICAL CASES, TECH STOOD BY THE OPERATING ROOM BED WHEN HIS HEAD RAN INTO THE OVERHEAD TRUMPF ILED 7 DUO LIGHT. WHEN HE ATTEMPTED TO MOVE THE LIGHT OUT OF THE WAY, THE LIGHT SEPARATED FROM THE BOOM THAT HELD IT AND FELL, STRIKING TECH IN THE HEAD. TECH HAD CONCUSSION DIAGNOSIS. ACCORDING TO THE HILLROM SERVICE TECH, THE LIGHT'S FAILURE OCCURRED DUE TO A SCREW BEING MISSING FROM A COUPLING THAT EXPOSES A DISK THAT HOLDS THE LIGHT IN PLACE. WITH THE DISK EXPOSED AND THE MOVEMENT OF THE LIGHT, THE DISK FELL OUT, AND THE LIGHT CAME DOWN WITH IT. THE MISSING SCREW AND DISK WERE REPLACED. THE SCREW IS VERY SMALL, THE DISC IS PLASTIC. THESE ARE POOR DESIGN CHOICES FOR THIS PIECE OF EQUIPMENT. MANY REPORTS OF THIS NATURE HAVE BEEN FILED OVER THE YEARS AS VIEWABLE IN MAUDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190102 TRUMPF ILED 7 LIGHT, SURGICAL, FLOOR STANDING FSS TRUMPF/BAXTER MEDICAL SYSTEMS GMBH + CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| O