MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG TRULIGHT 5000 / 3000 CEILING DUO; SURGICAL LIGHT

Model Number	4038210
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	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further investigation is ongoing and results will be provided by a final report.
Event or Problem Description
Customer reported damage to the sky lamp during cleaning.The lamp detached from the joint and caused damage to the ceiling and floor.No harm or injury to patient or caregiver was reported this report was filed in our complaint handling system as complaint#: (b)(4).
Additional Manufacturer Narrative
The field service of baxter performed an onsite investigation at the hospital.The failure "light detached from joint" could confirmed during the inspection.According to the inspection, the screw which secures the sleeve was missing.Following this, the sleeve was obviously unintentionally pushed upwards while the light was being cleaned, causing the locking segment to slip out of the groove and the light head fell down.The sleeve can only be moved if the screw to secure the sleeve against movement was forgotten to be installed or was removed without authorization.According to the service history review the last maintenance was carried out in april 2024.The screw was probably forgotten during this maintenance or was installed incorrectly.A further unauthorized manipulation of the screw can also not be ruled out but is unlikely.The affected parts were exchanged and the device is working as intended.Based on this, no further actions are required.
Event or Problem Description
Customer reported damage to the sky lamp during cleaning.The lamp detached from the joint and caused damage to the ceiling and floor.No harm or injury to patient or caregiver was reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: TRULIGHT 5000 / 3000 CEILING DUO
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: frances coote ; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 21376787
• Report Number: 3007143268-2025-00009
• Device Sequence Number: 12869772
• Product Code: FSY
• UDI-Device Identifier: 00887761995918
• UDI-Public: 887761995918
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 03/11/2025

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
• Device Model Number: 4038210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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