BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILED 7 SINGLE

    MDR report key: 7183078 · Received January 11, 2018

    Report

    Report Number
    9681407-2018-00004
    Event Type
    Injury
    Date Received
    January 11, 2018
    Date of Event
    December 15, 2017
    Report Date
    December 15, 2017
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A TRUMPF MEDICAL SERVICE TECHNICIAN INSPECTED THE LIGHT SYSTEM AND FOUND THE PRODUCT TO BE OPERATING WITHIN SPECIFICATION. THE TRUMPF MEDICAL QA/RA MANAGER VISITED THE SITE TO FURTHER INVESTIGATE THE INCIDENT. INTERVIEWS WITH HOSPITAL STAFF REVEALED THAT LIGHT PATTERNS FROM MULTIPLE LAMP HEADS WERE OVERLAPPED. THE USER MANUAL FOR THE ILED 7 LIGHTING SYSTEM STATES: "VISIBLE LIGHT GENERATES HEAT IN THE OPERATING AREA, DUE TO PHYSICAL EFFECTS. HIGH IRRADIATION DENSITIES ARE GENERATED WHEN THE LIGHT FIELDS OF SEVERAL LIGHT HEADS OVERLAP. THIS CAN CAUSE DRYING OF TISSUE AND, PARTICULARLY AFTER PROLONGED EXPOSURE, REDUCED PERFUSION AND TISSUE DAMAGE. THE LIGHT INTENSITY MUST BE REDUCED WHEN PERFUSION IS REDUCED OR THE TISSUE STARTS TO DRY OUT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED ALLEGED TISSUE DAMAGE AFTER A SURGICAL PROCEDURE IN WHICH TRUMPF MEDICAL SURGICAL LIGHTS WERE USED. THE PATIENT RECEIVED A VASELINE GAUZE DRESSING TO TREAT THE TISSUE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27464 ILED 7 SINGLE ILED 7 FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG I700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention