MAUDE Adverse Event Report: MAQUET SAS LUCEA LED®; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	ARDLCA219003A
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: (b)(6).The device reference number for the medical device referred to in this medical device report cannot be verified, and therefore, no udi number can be provided.Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - lucea 100.It was stated the underside cover was broken, resulting in missing particles.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
The correction of d1 brand name, d2a common device name and d2b product code for the fda (procode) fields deems required.This is based on the internal evaluation.Previous d1 brand name: lucea 100.Corrected d1 brand name: lucea led®.Previous d2a common device name: lamp, surgical.Corrected d2a common device name: light, surgical, ceiling mounted.Previous d2b product code for the fda (procode): ftd.Corrected d2b product code for the fda (procode): fsy.Getinge became aware of an issue with one of surgical lights - lucea 100.It was stated the underside cover was broken, resulting in missing particles.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification and in this way the device contributed to event.It is unknown if claimed devices were or were not being used for patient treatment or diagnosis when the event took place.Cracks located at the upper or lower cover, or at the edge of the on/off button, can have several root causes.It can be due to mechanical stress, use of inappropriate cleaning/disinfection products, or inappropriate cleaning and disinfection protocols.Collision with another devices can lead as well to cracks or breakages, particularly when some plastic parts are missing.If the described failure occurs, the user can visually detect it during the daily checks to be performed prior to each use, or during preventive maintenance.In this case, the user would contact a getinge representative to replace the defective covers of the affected device.To prevent any incident the lucea50-100 user manual mentions: ¿check the light heads for chipped paint, impact marks and any other damages¿ during the daily inspections.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• Brand Name: LUCEA LED®
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 21457031
• Report Number: 9710055-2025-0000077
• Device Sequence Number: 12759013
• Product Code: FSY
• UDI-Device Identifier: 03700712400620
• UDI-Public: (01)03700712400620
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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
• Operator of Device: Health Professional
• Device Model Number: ARDLCA219003A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown