BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRULIGHT 5000 / 3000 DUO

    MDR report key: 7650395 · Received June 29, 2018

    Report

    Report Number
    9681407-2018-00032
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    May 31, 2018
    Report Date
    May 31, 2018
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    PMA / PMN Number
    K102758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A TRUMPF MEDICAL FIELD SERVICE TECHNICIAN WAS DISPATCHED ON THE DAY OF THE COMPLAINT TO PERFORM AN INSPECTION OF THE TRULIGHT LAMP HEAD AND MOUNTING SYSTEM. THE INSPECTION REVEALED A PROBABLE DEVICE MALFUNCTION RELATED TO THE CRESCENT KEY FASTENER. THE CRESCENT KEY FASTENER MAINTAINS THE CONNECTION BETWEEN THE SPRING ARM AND CARDANIC ASSEMBLY (COMFORT ARM). THE INSPECTION ON (B)(4) 2018 ALSO REVEALED THAT THE LIKELY ROOT CAUSE OF THE LAMP HEAD DETACHMENT FROM THE MOUNTING SYSTEM WAS CAUSED BY THE SPRING ARM SAFETY-SLEEVE NOT BEING PROPERLY SECURED. AS A RESULT, THE CRESCENT KEY FASTENER MIGRATED OUT OF POSITION OVER MULTIPLE USES AND MULTIPLE SPRING ARM AND CARDANIC ASSEMBLY JOINT ARTICULATIONS WHILE POSITIONING THE LAMP HEAD. A DEFINITIVE ANSWER AS TO THE CAUSE OF THE MALFUNCTION CANNOT BE DETERMINED. AS SUCH, A TRUMPF MEDICAL FIELD SERVICE TECHNICIAN AND (B)(6) HOSPITAL'S FACILITIES ENGINEERING MANAGEMENT INSPECTED ALL TRUMPF MEDICAL LIGHT SYSTEMS IN THE (B)(6) HOSPITAL SURGICAL AREA TO VERIFY THE APPROPRIATE SPRING ARM SAFETY-SLEEVE INSTALLATION. THE FIELD SERVICE TECHNICIAN REPLACED THE TRULIGHT LAMP HEAD, SPRING ARM, AND CARDANIC ASSEMBLY FOR THE LIGHT SYSTEM.

    Description of Event or Problem · 1

    THE LAMP HEAD OF A TRUMPF MEDICAL SURGICAL LIGHT FELL AND STRUCK A PATIENT. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492294 TRULIGHT 5000 / 3000 DUO SURGICAL LIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 4038210

    Patients

    Seq Age Sex Outcome Treatment
    1