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

Model Number	4068210
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Baxter is in the process of inspecting the iled 7 surgical light.There was no allegation of patient or caregiver injury or death reported from this alleged incident.Investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
Event or Problem Description
The customer reported that the iled 7 surgical light fell down to the ground.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
The field service of baxter performed an onsite investigation at the hospital.The failure could confirmed during the inspection.During the on-site inspection, it was discovered that the screw used to secure the locking sleeve was missing.The retaining segment was still in the slot of the spring arm.The missing screw was traced to an installation failure during previous service events of the light system.Replaced kit 4 safety kit ac2000.Functioning as designed.Based on this, no further actions are necessary.
Event or Problem Description
The customer reported that the iled 7 surgical light fell down to the ground.There was no patient/user injury reported.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: 19557917
• Report Number: 3007143268-2024-00026
• Device Sequence Number: 14636205
• 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,Followup
• Report Date (Section B): 08/13/2024

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: 4068210
• 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: 05/25/2024
• Supplement Date Received by Manufacturer: 05/25/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/13/2024
• 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