MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG TRULIGHT 5000 / 3000 CEILING DUO; SURGICAL LIGHT

Model Number	4038210
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	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further investigation is ongoing and results will be provided by a final report.
Event or Problem Description
Customer reported the light head fell to the floor and the spring arm hit the ceiling after one staff member pulled the clip out of the connection.No harm or injury to patient or caregiver was reported.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
During onsite inspection, baxter technician confirmed the light head fell.An employee (electrician) of the facility pulled the safety segment out of the spring arm while working on the lighting system and the light head fell to the floor and the spring arm hit the ceiling.For maintenance it is required to remove the light head from the support arm system.During this, the light head fell based on a handling failure of the facility personnel.There was no impact to a surgical procedure and no identified device malfunction.The defect light head will be replaced.Based on this, not further actions are required.
Event or Problem Description
Customer reported the light head fell to the floor and the spring arm hit the ceiling after one staff member pulled the clip out of the connection.No harm or injury to patient or caregiver was reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: TRULIGHT 5000 / 3000 CEILING DUO
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: daniela avila ; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 18629136
• Report Number: 3007143268-2024-00003
• Device Sequence Number: 20821846
• Product Code: FSY
• UDI-Device Identifier: 00887761995918
• UDI-Public: 887761995918
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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
• Device Model Number: 4038210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 03/27/2024
• 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