MAUDE Adverse Event Report: MAQUET SAS LUCEA 50; LAMP, SURGICAL

Model Number	ARDLCA209012A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - lucea 50.It was stated the brake cover was missing from the device.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.
Additional Manufacturer Narrative
The correction of h3a device evaluated by manufacturer?, h3b device not eval provide code and h3c if other provide code -explain fields deems required.This is based on the internal evaluation.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.On 30th january, 2023 getinge became aware of an issue with one of surgical lights - lca 50.It was stated the brake cover was missing from the device.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.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.The claimed device was not being used for patient treatment or diagnosis when the event took place.Root cause analysis was performed by subject matter expert at manufacturer¿s.The analysis is following: according to the information collected the silicone cap, covering the brake, was probably removed during a cleaning procedure.It was a misuse.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: LUCEA 50
• Common Device Name: LAMP, SURGICAL
• 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: 16270786
• Report Number: 9710055-2023-00084
• Device Sequence Number: 7435340
• Product Code: FTD
• UDI-Device Identifier: 03700712400637
• UDI-Public: (01)03700712400637
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: ARDLCA209012A
• Device Catalogue Number: ARDLCA209012A
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown