MAUDE Adverse Event Report: MAQUET SAS LUCEA LED®; LIGHT, SURGICAL, FLOOR STANDING

Model Number	ARDLCA309006A
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - lucea 100 mobile.It was stated the power plug is coming out - one of the left and right prongs of the power plug was broken.The issue was confirmed by photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as contact of plug with live parts may cause electric shock in case of reoccurrence.
Additional Manufacturer Narrative
Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - lucea 100 mobile.It was stated the power plug is coming out - one of the left and right prongs of the power plug was broken.The issue was confirmed by photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as contact of plug with live parts may cause electric shock in case of reoccurrence.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.There is no information if the claimed device was or was not being used for patient treatment or diagnosis when the event took place.The analysis related to the reported issue has been performed by the subject matter expert at the manufacturing site.As it stated, the dimensions of the electrical socket support showed no discrepancies (the support is in accordance with the plan).The new socket iec has allowed the product to be brought into compliance.We can conclude that the thickness of the frame is compliant.Only the hooks of electrical socket are broken.The most probable cause of broken of the electrical socket is misuse.After a lateral shock or an excessive effort during the extraction of the electrical cable.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, FLOOR STANDING
• 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: 21026100
• Report Number: 9710055-2024-0000645
• Device Sequence Number: 9052302
• Product Code: FSS
• UDI-Device Identifier: 03700712400712
• UDI-Public: (01)03700712400712
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2024

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
• Operator of Device: Health Professional
• Device Model Number: ARDLCA309006A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown