BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILED DUO

    MDR report key: 7872146 · Received September 13, 2018

    Report

    Report Number
    9681407-2018-00048
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    August 14, 2018
    Report Date
    August 14, 2018
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    PMA / PMN Number
    K061317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS KNOWN THAT IMPROPER INSTALLATION, MAINTENANCE, OR COLLISION CAN LEAD TO THE SPRING ARM COVERS FALLING OFF. THE DEVICE WAS INSPECTED BY A TRUMPF MEDICAL SERVICE TECHNICIAN AND REPAIRED.

    Description of Event or Problem · 1

    WHILE USER FACILITY STAFF WAS CLEANING A TRUMPF MEDICAL SURGICAL LIGHT SYSTEM, THE PLASTIC STRIP OF A ILED DUO'S SPRING ARM JOINT COVER BECAME SEPARATED AND FELL AFTER A COLLISION. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715046 ILED DUO SURGICAL LIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 4028210

    Patients

    Seq Age Sex Outcome Treatment
    1