MAUDE Adverse Event Report: MAQUET SAS LUCEA 10; 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 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2021 getinge became aware of an issue with lucea 10 device.As it was stated, the cover was broken off.There was no injury reported, however, we decided to report the issue in abundance of caution as any detachment of part or particles may lead to potential infection of the patient.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with lucea 10 device.As it was stated, the cover was broken off.There was no injury reported, however, we decided to report the issue in abundance of caution as any detachment of part or particles may lead to potential infection of the patient.It was established that when the event occurred, the light did not meet its specification as the cover was broken off and it contributed to event.There is no information whether the device was or was not being used for patient treatment.According to information provided by sales and service unit, the cover was broken due to crash.Probable root cause is improper use or improper handling of equipment.It is necessary to refer to the instruction manual for more information (ifu 01701 en 10 2021-03-17 page 21).We believe that this type of our devices are performing correctly in the market.

• Brand Name: LUCEA 10
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11900438
• MDR Text Key: 253140661
• Report Number: 9710055-2021-00208
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/03/2021
• Patient Sequence Number: 1