BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRULIGHT DUO

    MDR report key: 7790301 · Received August 16, 2018

    Report

    Report Number
    9681407-2018-00039
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    July 17, 2018
    Report Date
    July 20, 2018
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSQ
    PMA / PMN Number
    K102758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT'S TECHNICIAN RECEIVED A REQUEST TO ADJUST THE LIGHT DUE TO A DRIFTING LIGHT HEAD. WHILE ADJUSTING THE LIGHT, THE SPRING ARM SEPARATED FROM THE CENTRAL AXIS, KNOCKING THE ACCOUNT'S TECHNICIAN FROM HIS LADDER TO THE FLOOR. THE LIGHT STRUCK HIM AND HE SUFFERED A LACERATION ABOVE HIS EYE THAT REQUIRED SIX STITCHES. HE ALSO STRUCK HIS HEAD ON THE FLOOR THEN UNDERWENT A CT SCAN AND X-RAY. HE WAS LATER DIAGNOSED WITH A CONCUSSION AND PLACED ON LIGHT DUTY RESTRICTION AT WORK. THE HILL-ROM FIELD SERVICE TECHNICIAN CONFIRMED THE NARRATIVE GIVEN BY THE ACCOUNT'S TECHNICIAN. HE FOUND THE FAILURE WAS LIKELY DUE TO THE IMPROPER INSTALLATION OF THE SNAP RING AT THE SPRING ARM - CENTRAL AXIS JOINT. THE SNAP RING WILL BE REPLACED ONCE THE REPLACEMENT PARTS ARRIVE.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE SPRING ARM SEPARATED FROM THE CENTRAL AXIS, FELL AND STRUCK A FACILITY SERVICE TECHNICIAN. THE LIGHT WAS LOCATED AT THE ACCOUNT. THERE WAS A MODERATE INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629294 TRULIGHT DUO SURGICAL LIGHT FSQ TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 1574850

    Patients

    Seq Age Sex Outcome Treatment
    1