MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TRULIGHT TRIO; SURGICAL LIGHT

Model Number	1574851
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: TRULIGHT TRIO
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM COMPANY INC.; 4279 u crosspoint drive; ladson SC 29456
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22132961
• Report Number: 3003184737-2025-00001
• Device Sequence Number: 7343094
• Product Code: FSY
• UDI-Device Identifier: 00887761968394
• UDI-Public: (01)00887761968394(11)121214
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 1574851
• Device Catalogue Number: 1574851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown