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

Model Number 4068210

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Concussion (2192)

Event Date 06/08/2023

Event Type  malfunction  

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 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
• 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: frances coote ; carl zeiss strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 17223600
• MDR Text Key: 318082084
• Report Number: 3007143268-2023-00025
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00887761995857
• UDI-Public: 887761995857
• 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
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• 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
• Date Manufacturer Received: 06/08/2023
• 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