MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ILED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	4068210
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Codes	Head Injury (1879); Pain (1994); Concussion (2192)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a surgeon hit their head on an iled light and sustained a concussion.The surgeon was performing a procedure on a patient when the physician ¿moved to get around the patient's knee¿ and hit their head ¿violently¿ on the handle/camera of the light fixture.The surgeon complained of pain and dizziness.The surgeon had to sit down ¿until they regained their senses.¿ the surgeon experienced pain for a few days in which they took unspecified ¿pain killers.¿ currently the physician has recovered.Additionally, it was reported the surgeon was tall and the operating room ¿the iled7 lights remain to be too low despite the change of the lights spring arm from normal height to the ones dedicated for low ceilings¿ in 2025.The iled 7 device instruction for use warns ¿a collision involving the support arms or lamp head can result in damage.Avoid collisions with other objects or adjacent walls.Before adjusting the height, check that there is sufficient ceiling clearance and ensure that there are no other objects positioned above the lamp head.Furthermore, the instructions for use state ¿before the medical device is applied, the user must ensure that the product is operational and in an appropriate state and the user must further have read the instructions for use as well as other, attached, safety-relevant information and maintenance instructions.Carry out a function test and visual inspection on the surgical light system before and after each use, including but not limited to checking for loose parts and damaged covers.¿ 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
The ultimate cause of the reported event is unknown; however, the customer attributes the event to the ¿low ceiling¿ height in the associated operating room combined with the caregiver being ¿tall.¿ additionally, the customer continued to use the alleged ¿low lights¿ post-installation, as well as post adjustment (july 2025), at which time it is noted the light adjustment was tested with the facility¿s staff and biomed representatives, thus, use error cannot be excluded as a contributing factor to the injury.Thus the condition would not cause or contribute to serious injury if it were to recur.
Additional Manufacturer Narrative
F10/h6: correction.Based on the available information and the inspection performed, a component-related defect can be excluded.The observed behavior of the or light resulted from normal, usage-related wear of the brake screws.According to the operating instructions (ga 7990087_01_08, among others section 4.6.8), users are explicitly advised to readjust or have the brake screws adjusted when signs of wear occur.Due to the worn brake screw, the light lowered under its own weight and, after a certain amount of time, was lower than the position previously set by staff, which led to it colliding with the doctor¿s head.After being correctly adjusted by the technician, the lamp no longer lowered on its own and could be smoothly adjusted to all positions.This was a partial user error on the part of the customer, as the brake screw was not readjusted or requested to be readjusted in good time.Spring arm set screw was loose, will have to adjust it accordingly to avoid drifting of the iled7 light head.Adjusted the set screw for the spring arm assembly, light head is not drifting up and down anymore.Rotating very smoothly, doublechecked rotation smoothness and adjusted well.Drifting issue eliminated.Rotating and moving very well as intended.

• Brand Name: ILED
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• 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 ; 2242705355
• MDR Report Key: 24329433
• Report Number: 3007143268-2026-00004
• Device Sequence Number: 4812590
• Product Code: FSY
• UDI-Device Identifier: 00887761995857
• UDI-Public: (01)00887761995857
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/16/2026; 05/04/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/16/2026; 05/04/2026
• 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