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

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/18/2024

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 18th january, 2024 getinge became aware of an issue with one of our examination lights ¿ lucea 40.During preventive maintenance it was found that plastic part of the dome was damaged and needed to be replaced, also that the dome was damaged.According to the technician the problem was due to a fragility of the dome.Photographic evidence indicated that the headlight was taped.There was no injury reported, however, considering the worse case scenario some parts or particles of the headlight could detach from the device and fall off, therefore we decided to report this issue in abundance of caution as any parts or particles falling off during examination may lead to potential infection of the patient.

• 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: 18628999
• MDR Text Key: 334403850
• Report Number: 9710055-2024-00120
• 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: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1