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	08/28/2024
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 that they saw a screw of the monitor bracket loose.When they moved the bracket, the monitor bracket broke, the monitor came loose and burst the fiber optic cables.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
Baxter field service performed an onsite investigation at the hospital.The failure could be confirmed during the inspection.The cause of the component breakage is an incorrect screw torque during production by the supplier of the bracket.The supplier has initiated appropriate measures to prevent the error in the future (introduction of torque wrenches).The product involved in this event was manufactured before the introduction of this measure.After replacing the monitor bracket the device is working as designed.Based on this, no further action is required.
Event or Problem Description
Customer reported that they saw a screw of the monitor bracket loose.When they moved the bracket, the monitor bracket broke, the monitor came loose and burst the fiber optic cables.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: frances coote ; carl-zeiss strasse 7-9; saalfeld 07318 ; GM 07318
• MDR Report Key: 20245805
• Report Number: 3007143268-2024-00044
• Device Sequence Number: 7282704
• Product Code: FSY
• UDI-Device Identifier: 00887761995918
• UDI-Public: 887761995918
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 11/07/2024

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: 08/28/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 11/07/2024
• 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