MAUDE Adverse Event Report: MAQUET SAS LUCEA 10/40; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number ARD569065999

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of our examination lights - lucea 10/40.It was stated the lamp housing was broken.Photographic evidence confirmed that issue and indicated that some cover particles were missing.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off during examination may lead to potential infection of the patient.

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of b5 describe event and problem, d1 brand name and d2a product code for the fda deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 26th october, 2023 getinge became aware of an issue with one of our examination lights - lucea 10/40.It was stated the lamp housing was broken.Photographic evidence confirmed that issue and indicated that some cover particles were missing.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off during examination may lead to potential infection of the patient.Corrected b5 describe event and problem: on 26th october, 2023 getinge became aware of an issue with one of our surgical lights - lucea 50/100.It was stated the lamp housing was broken.Photographic evidence confirmed that issue and indicated that some cover particles were missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.Previous d1 brand name: lucea 10/40.Corrected d1 brand name: lucea 50/100.Previous d2a product code for the fda: kzf.Corrected d2a product code for the fda: ftd.

Event Description

On 26th october, 2023 getinge became aware of an issue with one of our surgical lights - lucea 50/100.It was stated the lamp housing was broken.Photographic evidence confirmed that issue and indicated that some cover particles were missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.

• Brand Name: LUCEA 10/40
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• 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: 18167768
• MDR Text Key: 328484916
• Report Number: 9710055-2023-00893
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD569065999
• Device Catalogue Number: ARD569065999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1