BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRULIGHT TRIO

    MDR report key: 22132961 · Received June 3, 2025

    Report

    Report Number
    3003184737-2025-00001
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    May 8, 2025
    Report Date
    June 26, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FSY
    UDI-DI
    00887761968394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INSPECTION OF THE DEVICE IS PENDING AND RESULTS WILL BE PROVIDED BY A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE TRULIGHT TRIO IS INTENDED TO BE USED TO PROVIDE VISIBLE ILLUMINATION OF THE SURGICAL FIELD OR THE PATIENT. BASED ON THE INFORMATION PROVIDED BY THE TECHNICIAN, IT CAN BE ASSUMED THAT THE LIGHT HEAD TRULIGHT 5520 FELL DURING CLEANING AND THE MONITOR ARMWAS ALREADY PLACED ON THE OPERATING TABLE DUE TO SERVICE WORK BY THE SERVICE PROVIDER. THE EVENT COULD NOT BE CONFIRMED. THE VISUAL EVIDENCE PROVIDED SHOWS HOW THE SLEEVE ON THE AC2000 SPRING ARM, TO WHICH THE LIGHT HEAD IS ATTACHED, HAS BEEN PUSHED UPWARDS. THIS CAN ONLY HAPPEN IF THE SAFETY SCREW OF THE SLEEVE IS MISSING. THE SLEEVE COVERS THE RETAINING SEGMENT AND IS SECURED BY THE SCREW. IF THE SCREW IS MISSING, THE SLEEVE CAN BE PUSHED UPWARDS (E.G. DURING CLEANING), EXPOSING THE RETAINING SEGMENT. WHEN THE LIGHT HEAD MOVES, THE RETAINING SEGMENT IN THE SPRING ARM MOVES OUT OF THE GROOVE IN THE COMFORT BRACKET, AND THE BRACKET SLIDES OUT OF THE SPRING ARM ALONG WITH THE LIGHT HEAD AND FALLS DOWN. THIS EXPLAINS WHY THE LIGHT HEAD FELL DOWN DURING CLEANING. IT IS NOT POSSIBLE TO DETERMINE WHY THE SCREW WAS MISSING, AS THE PREVENTIVE MAINTENANCE AND SERVICE WORK IS CARRIED OUT BY THE SERVICE PROVIDER COMMISSIONED BY THE CUSTOMER. PRESUMABLY, THE LIGHT HEAD WAS DISASSEMBLED DURING INSTALLATION OF THE LED MODULE, AND THE LOCKING SCREW FOR THE SLEEVE WAS FORGOTTEN OR NOT PROPERLY SECURED DURING ASSEMBLY, CAUSING IT TO LOOSEN OVER TIME. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED. THE LIGHTING SYSTEM WAS MANUFACTURED AND INSTALLED IN 2012. DUE TO THE AGE OF THE PRODUCT, MAINTENANCE IS REQUIRED EVERY TWO YEARS PER THE IFU DOCUMENT. THE PRODUCT WILL BE MAINTAINED BY THIRD PARTY SERVICE PROVIDER. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF A TRULIGHT SEPARATING FROM THE BOOM AND FALLING, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRULIGHT TRIO HAD AN ISSUE, DUAL MONITOR SUPPORT SEPARATED FROM THE BOOM AND IS RESTING ON THE OPERATING ROOM TABLE. ADDITIONALLY, THE LIGHT FIXTURE SEPARATED FROM THE BOOM AND FELL DAMAGING THE FIXTURE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRULIGHT TRIO HAD AN ISSUE, DUAL MONITOR SUPPORT SEPARATED FROM THE BOOM AND IS RESTING ON THE OR TABLE. ADDITIONALLY THE LIGHT FIXTURE SEPARATED FROM THE BOOM AND FELL DAMAGING THE FIXTURE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357754 TRULIGHT TRIO SURGICAL LIGHT FSY BAXTER HEALTHCARE CORPORATION 1574851 00887761968394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown