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

Model Number 4038210

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

Further investigation is ongoing and results will be provided by a final report.

Event 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).

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 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
• Type of Device: 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
• MDR Text Key: 334516242
• Report Number: 3007143268-2024-00003
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00887761995918
• UDI-Public: 887761995918
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1