BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILED7

    MDR report key: 8090346 · Received November 20, 2018

    Report

    Report Number
    9681407-2018-00069
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    October 24, 2018
    Report Date
    October 24, 2018
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INSPECTION, THE TECHNICIAN FOUND THAT THE LIGHT WAS IMPROPERLY ASSEMBLED. THE ROOT CAUSE WAS THE IMPROPER INSTALLATION OF THE STOP SCREW. THE SCREW WAS ADJUSTED AND DEVICE IS FUNCTIONING AS DESIGNED. THE MOBILE STAND VERSION HAS A HIGH TILTING STABILITY. THE FOLLOWING, BASIC PRECAUTIONS MUST BE CONSIDERED WHEN POSITIONING THE MOBILE STAND VERSION. THE STAND MIGHT TILT WHEN THE ROLLERS ARE LOCKED AND EXCESSIVE FORCE IS EXERTED ONTO THE SPRING ARM OR LIGHT HEAD. USER SHOULD AVOID STRONG LEVERAGE ONTO THE SPRING ARM OR THE LIGHT HEAD AND NOT ADD ADDITIONAL LOADS TO THE SPRING ARM.

    Description of Event or Problem · 1

    DURING ARTICULATION, THE SPRING ARM ROTATED PAST ITS INTENDED STOP AND THE MOBILE LIGHT TIPPED. NO PATIENT OR CAREGIVER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932903 ILED7 MOBILE LIGHT FSQ TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 4068120

    Patients

    Seq Age Sex Outcome Treatment
    1