BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILED DUO

    MDR report key: 7152057 · Received December 28, 2017

    Report

    Report Number
    9681407-2017-00048
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    December 1, 2017
    Report Date
    December 1, 2017
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    PMA / PMN Number
    K061317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TRUMPF MEDICAL SERVICE TECHNICIAN INSPECTED THE LIGHT SYSTEM AND FOUND THE THE RETAINING SEGMENT GROOVE WAS WORN. THIS ALLOWED THE MONITOR BRACKET TO DESCEND BELOW THE SPRING ARM'S STOP. THE SERVICE TECHNICIAN REPLACED THE FLAT PANEL BRACKET AND THE DEVICE OPERATED AS INTENDED.

    Description of Event or Problem · 1

    THE FLAT PANEL BRACKET OF A TRUMPF MEDICAL SURGICAL LIGHT BEGAN TO SEPARATE FROM THE SPRING ARM, ALLOWING IT TO FREELY ROTATE BEYOND THE STOPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930183 ILED DUO SURGICAL LIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 1565160

    Patients

    Seq Age Sex Outcome Treatment
    1