BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILED 7 DUO

    MDR report key: 8520688 · Received April 16, 2019

    Report

    Report Number
    9681407-2019-00008
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 19, 2019
    Report Date
    March 19, 2019
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A TRUMPF MEDICAL SERVICE TECHNICIAN INSPECTED THE ILED 7 DUO SURGICAL LIGHT SYSTEM AND CONFIRMED THAT THE SPRING ARM WAS SEPARATING FROM THE CENTRAL AXIS. THE CIRCLIP AND WASHERS WERE REPLACED PROPERLY AND THE LIGHT FUNCTIONED AS INTENDED. A FIELD CORRECTIVE ACTION HAS BEEN INITIATED BY TRUMPF MEDICAL AND REPORTED TO THE FDA AS A RESULT OF INVESTIGATIONS INTO SIMILAR EVENTS (RECALL NUMBER Z-563-2016). THE INVESTIGATIONS HAVE FOUND THAT IMPROPER INSTALLATION OR SERVICING OF THE CIRCLIP IN THIS JOINT CAN RESULT IN THE SLIPPING DOWN OR FALLING OF THE SPRING ARM AND LIGHT HEAD COMPONENTS.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT THE SPRING ARM OF A TRUMPF MEDICAL SURGICAL LIGHT WAS SEPARATING FROM THE CENTRAL AXIS ARM. NO INJURY OR PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314422 ILED 7 DUO SURGICAL LIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 4068210

    Patients

    Seq Age Sex Outcome Treatment
    1