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

Model Number ARD568601998

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

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

Event Date 01/17/2024

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 17th january, 2024 getinge became aware of an issue with one of examination lights - lucea 40.It was stated the plastic part of dome is broken with missing particles.We decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause infection.

• 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: 18595419
• MDR Text Key: 333965552
• Report Number: 9710055-2024-00096
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568601998
• Device Catalogue Number: ARD568601998
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1