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

Model Number	4068310
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information is available on the repair of the device at this time.The investigation is ongoing, however if any additional relevant information is identified following the completion of the investigation, the additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
Baxter received a report that iled7 trio/quad had spring arm falling off the center axis.The process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
During inspection it was found that the circlip not holding up the arm.The preventive maintenance has not been maintained.The lighting system was installed in 2018 and the maintenance is carried out by the customer and not by baxter.Due to the age of the lighting system (delivered in 2018), maintenance should be carried out every 2 years.It is conceivable that wear and tear over time has led to the locking ring failing.The ifu warning the user to provide a preventive maintenance as follow: the surgical light system must be serviced at least every 2 years after handover to the user.After ten years of operation, maintenance of the surgical light must be carried out annually.Product maintenance or the exchange of components may only be carried out by qualified service technicians.The contact details of service technicians can be obtained from the technical customer service at baxter.Baxter recommends concluding a maintenance agreement, so that maintenance can be carried out promptly and reliably.The technician replaced the spring arm to resolve the reported event.Based on this information, no further action is required.Although there was no reported injury with this event, if the report of a device/heavy part falling were to recur, it could potentially cause serious injury or death.Therefore, baxter is reporting this event.

• 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: 24736185
• Report Number: 3007143268-2026-00021
• Device Sequence Number: 21380243
• Product Code: FSY
• UDI-Device Identifier: 00887761995840
• UDI-Public: (01)00887761995840
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: Other
• Device Model Number: 4068310
• Device Catalogue Number: 4068310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/28/2026
• 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
• Patient Sex: Unknown