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

Model Number	ARDLCA219003A
Medical Device Problem Code	Grounding Malfunction (1271)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter was medical technology/house technology department.Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
On 16th february, 2024 getinge became aware of an issue with one of surgical lights - lucea 100.As it was stated, the customer operated the light without the associated power supply, which meant there was no galvanic isolation from the house's power supply.There was no injury reported, however, we decided to report the issue in abundance of caution as lack of grounding could lead to overheating of components in case of reoccurrence.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
The correction of d1 brand name, d2 product code., d4 catalog #, d4 version of model #, d4 unique identifier (udi) and h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous d1 brand name: lucea 100.Corrected d1 brand name: lucea led®.Previous d2 product code.: ftd.Corrected d2 product code.: fsy.Previous d4 version of model # ard568603999.Corrected d4 version of model # ardlca219003a.Previous d4 catalog # ard568603999.Corrected d4 catalog # none.Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.Getinge became aware of an issue with one of surgical lights - lucea 100.As it was stated, the customer operated the light without the associated power supply, which meant there was no galvanic isolation from the house's power supply.There was no injury reported, however, we decided to report the issue in abundance of caution as lack of grounding could lead to overheating of components in case of reoccurrence.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 not being used for patient treatment or diagnosis when the event took place.The lack of earth connections observed is clearly a non compliance with all recommendations and warnings mentioned in our installation manuals.For future installations we recommend to carefully follow the instructions provided.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: 18874560
• Report Number: 9710055-2024-00208
• Device Sequence Number: 14215131
• Product Code: FSY
• UDI-Device Identifier: 03700712400620
• UDI-Public: (01)03700712400620
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/11/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDLCA219003A
• Device Catalogue Number: ARD568603999
• 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: 02/16/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown