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

Model Number ARD568602989

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

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

Event Date 05/22/2023

Event Type  malfunction  

Event Description

On 22nd may, 2023 getinge became aware of an issue with one of examination lights - lucea 10.Based on photographic evidence the headlight covers were cracked with missing particles.We decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause contamination.

Manufacturer Narrative

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

• 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: 17009364
• MDR Text Key: 316000899
• Report Number: 9710055-2023-00399
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 05/26/2023

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
• Device Model Number: ARD568602989
• Device Catalogue Number: ARD568602989
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/30/2012
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1