BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIGHT 5000/3000

    MDR report key: 7379197 · Received March 28, 2018

    Report

    Report Number
    9681407-2018-00015
    Event Type
    Injury
    Date Received
    March 28, 2018
    Date of Event
    March 8, 2018
    Report Date
    March 8, 2018
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    PMA / PMN Number
    K102758
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 SERVICE DIRECTOR 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 TRULIGHT LIGHTING SYSTEM HAS WARNINGS AGAINST OVERLAPPING FIELDS OF ILLUMINATION FROM SEVERAL LIGHT HEADS.

    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 COOL DRESSING TO AFFECTED SKIN AREAS AS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222639 TRULIGHT 5000/3000 TRULIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG T550-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention