MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG ILED 7 CEILING DUO; SURGICAL LIGHT

Model Number	4068210
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was identified that the screw which holds the retaining sleeve in place was missing.This allowed the retaining sleeve to move from its position and following the retaining segment to come out from the spring arm ¿ light bracket connection.As a result the light head detached and fell off.The missing screw was traced to an installation failure during previous service events of the light system.The light head was re-installed by the use of a new retaining segment and sleeve with screw.Based on this, no further actions are necessary.
Event or Problem Description
The customer alleged that the room was being cleaned after a case.The cleaning technician adjusted light up to clean table, a few seconds later the light head fell hitting the cleaning tech in the head and then light head fell to floor.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: ILED 7 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 thuringen 07318 ; GM 07318
• MDR Report Key: 17223600
• Report Number: 3007143268-2023-00025
• Device Sequence Number: 7097926
• Product Code: FSY
• UDI-Device Identifier: 00887761995857
• UDI-Public: 887761995857
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2023

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: 4068210
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 06/29/2023
• 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