MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ILED7 SURGICAL LIGHT

Model Number	4068210
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was inspected by a field service technician.It was identified during the inspection that a circlip came loose, causing the spring arm to slip out of the central axis and fall.The light system was installed in 2022 by baxter¿s installation team.The regularly maintenance was done by customer, baxter did not perform any preventive maintenance on this iled7 light system after initial installation.It is not known whether the customer has performed regular maintenance according to baxter specifications.According to the instructions for use preventive maintenance should be carried out every 2 years.By checking the system every 2 years, as recommended in the ifu and performed according to the maintenance instructions, it allows an incorrectly installed circlip to be identified and corrected.The issue was most likely caused by an installation error, as the circlip was not properly locked.The operating light system was repaired and is working as intended.Based on the investigation results no further actions are necessary.
Event or Problem Description
Baxter received a report stating that iled7 duo light head fell to the floor.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Event or Problem Description
Baxter received a report stating that iled7 duo light head fell to the floor.No harm or significant impact to the surgical procedure was reported.

• Brand Name: ILED7 SURGICAL LIGHT
• Common Device Name: SURGICAL LIGHT
• 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: 22699960
• Report Number: 3007143268-2025-00062
• Device Sequence Number: 15705973
• Product Code: FSY
• UDI-Device Identifier: 00887761995857
• UDI-Public: (01)00887761995857(11)220722
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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
• Operator of Device: Health Professional
• Device Model Number: 4068210
• Device Catalogue Number: 4068210
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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