MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ILED7 SURGICAL LIGHT; LIGHT, SURGICAL, INSTRUMENT

Model Number	4068210
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an iled 7 ceiling duo burned a patient.During an unspecified surgical procedure, the surgical team found the patient¿s skin was ¿like peeling at back of the patient¿ and temperature where the light was focused on the patient¿s back was hotter compared to the other parts of the patient¿s body.The patient was treated with cold fluids applied to the affected area.The biomedical department did an investigation by focusing the light on one spot and found that the area where it was focused on was hot and reached a temperature of 43 degrees celsius.The light default normal settings are 50%; however, the operating room team can increase them during the procedure if needed.The baxter technician checked the software of the light and found that all are up to date.Multiple attempts to obtain additional information were unsuccessful.No further information was available at the time of this report.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, h3, h6, h7, h9 and h11.H11: a qualified baxter technician was sent to the site and inspected the lighting system and found the lights to be performing according to product specifications.All fa-2024-035 information is now available at the customer site.On august 7, 2025, it was confirmed that the default setting for light intensity when switching on the lights is 50%.On august 25, 2025, the exchange of the ipad was replaced.In summary, due to the overlap of light fields with high intensity settings without the use of autofocus, the illumination intensity in the surgical area was increased.This can occur with 3 lights, but also with 2 lights with high intensity settings.The customer has been educated on the correct use of the device.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ILED7 SURGICAL LIGHT
• Common Device Name: LIGHT, SURGICAL, INSTRUMENT
• 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: 22895897
• Report Number: 3007143268-2025-00069
• Device Sequence Number: 8896977
• Product Code: FSQ
• UDI-Device Identifier: 00887761968295
• UDI-Public: (01)00887761968295
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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
• Operator of Device: Health Professional
• Device Model Number: 4068210
• Device Catalogue Number: 4068210
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/24/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3007143268-05/24/24-001-
• Patient Sequence Number: 1
• Patient Sex: Unknown