MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ILED7 SURGICAL LIGHT; LAMP, OPERATING-ROOM

Model Number	4068110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Hematoma (1884)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: the device was evaluated onsite by a qualified technician.During visual inspection, the device was noted to be too low.The reported condition was verified.To rectify the situation the one arm will be replaced to raise the height of the light to prevent staff from hitting the light equipment.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported an unspecified quantity of healthcare professionals sustained an array of ¿head injuries¿ due to the height of the iled7 surgical light.In operating room # 6 the ceiling is low, and this caused the height of the iled surgical light to be lower as well.Furthermore, the nurses and surgeons have sustained contusions and hematomas.One nurse is on ¿sick leave¿ after sustaining an unspecified ¿head injury¿ from the impact with the operating light.There was no alleged malfunction of the iled light.Additionally, the customer continued to use the alleged ¿low lights¿ post-installation, thus, use error cannot be excluded as a contributing factor to the injury.Furthermore, prevention of this type of event is outlined in the device instructions for use.No further information was available at the time of this report.

• Brand Name: ILED7 SURGICAL LIGHT
• Common Device Name: LAMP, OPERATING-ROOM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl zeiss strasse 7-9; saalfeld, thuringen 7318 ; GM 7318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22194044
• Report Number: 3007143268-2025-00046
• Device Sequence Number: 18448441
• Product Code: FQP
• UDI-Device Identifier: 00887761968325
• UDI-Public: (01)00887761968325
• 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
• Report Date (Section B): 06/12/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 4068110
• Device Catalogue Number: 4047020
• 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: 05/16/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown