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

Model Number ARD568601998

Device Problems Fracture (1260); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

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

Event Date 08/25/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of our examination lights - lucea 40 (mobile version).It was stated the lamp body could not be used because part of the lamp was damaged.According to the photographic evidence the cover was broken with missing particles which results in headlight detachment, the label on fork was damaged with risk of missing particles and paint was peeling from fork.The hospital staff noticed the cover damage while checking the operation, the lamp is not in use.There was no injury reported, however we decided to report the issue in abundance of caution as any parts or particles falling off during examination may lead to potential infection of the patient.

Manufacturer Narrative

(b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

• Brand Name: LUCEA 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: 17710704
• MDR Text Key: 322952716
• Report Number: 9710055-2023-00669
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• 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: 08/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/14/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1