BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILED DUO

    MDR report key: 7658205 · Received July 3, 2018

    Report

    Report Number
    9681407-2018-00033
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 4, 2018
    Report Date
    June 4, 2018
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    PMA / PMN Number
    K061317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TRUMPF MEDICAL SERVICE TECHNICIAN INSPECTED THE LIGHT SYSTEM AND FOUND THAT THE SLEEVE WAS NOT POSITIONED CORRECTLY BY A THIRD-PARTY VENDOR. THE SERVICE TECHNICIAN REPOSITIONED THE SLEEVE AND THE DEVICE OPERATED AS INTENDED.

    Description of Event or Problem · 1

    THE FLAT PANEL BRACKET OF A TRUMPF MEDICAL SURGICAL LIGHT HAD BEGUN TO SEPARATE FROM ITS SPRING ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499711 ILED DUO SURGICAL LIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 4028210

    Patients

    Seq Age Sex Outcome Treatment
    1