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

Model Number	4038110
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2024
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
It was reported that while one of the nurses was moving the head light, the trulight fell from the spring arm and hit the nurse on the calf.The nurse was admitted to the ed, released shortly after, and returned to work the day after the reported event.This report was filed in our complaint handling system as complaint (b)(4).
Event or Problem Description
It was reported that while one of the nurses was moving the head light, the trulight fell from the spring arm and hit the nurse on the calf.The nurse was admitted to the ed, released shortly after, and returned to work the day after the reported event.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The device is intended to be used to provide visible illumination of the surgical field or the patient.Upon inspection, it was determined that the screw for the retaining sleeve was missing, which caused the retaining segment to slip out and the light head to fall down.The failure was resolved by reinstalling the light head to the spring arm appropriate to the service manual.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the report of a light head detached from spring arm were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.

• Brand Name: TRULIGHT 5000 / 3000 CEILING SINGLE
• 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: 18825636
• Report Number: 3007143268-2024-00010
• Device Sequence Number: 12709292
• Product Code: FSY
• UDI-Device Identifier: 00887761995925
• UDI-Public: 887761995925
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/07/2024

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: 4038110
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 05/07/2024
• 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