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

Model Number 4038110

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event 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 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).

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
• 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: 18825636
• MDR Text Key: 336767211
• Report Number: 3007143268-2024-00010
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00887761995925
• UDI-Public: 887761995925
• 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: 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
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 05/07/2024
• 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