MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG ILED 7 CEILING TRIO; SURGICAL LIGHT

Model Number	4068310
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Baxter is in the process of inspecting the iled 7.Investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
Event or Problem Description
The customer alleged that during a surgical procedure, the iled surgical light system burned a patient.Follow-up with the customer found that the burn was reported to be a full thickness burn and ¿would require additional surgery to manage the burn.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 light system involved was inspected and confirmed it is working as designed.No defect or malfunction was identified.During further follow-up with the customer the outcome "thermal injury of patients skin during procedure" could be confirmed.The customer stated that two light heads were being used at 80% intensity at the same location for 2-2,5 hours.The root caused was traced to a user error by overlapping two light fields with high intensity.This issue was already investigated by an internal capa and resulted in a field action with the fda reference numbers z-2313-2024, z-2314-2024, and z-2315-2024 (res 94766) which is currently ongoing.Based on this, no further actions are necessary.
Event or Problem Description
The customer alleged that during a surgical procedure, the iled surgical light system burned a patient.Follow-up with the customer found that the burn was reported to be a full thickness burn and ¿would require additional surgery to manage the burn.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: ILED 7 CEILING TRIO
• 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: 21490523
• Report Number: 3007143268-2025-00016
• Device Sequence Number: 8436198
• Product Code: FSY
• UDI-Device Identifier: 00887761995840
• UDI-Public: 887761995840
• 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): 05/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 4068310
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 05/07/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown