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

Model Number ARD568602971

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

Getinge became aware of an issue with one of devices- lucea 10 examination light.It was reported to us initially that the suspension arm almost detached from the main tube.There was no injury reported however we decided to report the issue based on the received indication and in abundance of caution as a situation in which a suspension arm would actually detach may lead to serious injury.None of information available to date suggests that at the time when the event occurred the device was being used for the patient treatment.The device involved in this event has been identified as a lucea 10 model with the serial number (b)(4) and catalog number ard568602971.The manufacturing date of the device is 14th september, 2017.Installation was performed in (b)(6) 2018.Device history record was reviewed and no anomalies were found.Based on the investigation performed we were able to establish that the arm in question has a steel tube with 2mm wall thickness, therefore heavy loads or impacts are necessary to create a defect such as the one described with this case.The likeliness of such impact having taken place was also confirmed by the orientation of the crack and deformation of the arm that was returned to manufacturer for inspection.It was therefore established that when the event occurred, the examination light did not meet its specification and it contributed to the event since it was damaged.Additionally during the inspection and per the design specifications it has been confirmed that if the cylinder pin is still present in the suspension arm assembly the arm in fact could not have detached even when the weld malfunction occurs.We believe that this type of our devices are performing correctly in the market.We also believe that if the manufacturer recommendation as described in the instructions for use and pertaining to avoidance of collisions and checks before use would have been followed the incident could have been avoided.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On (b)(6) 2019 getinge became aware of an issue with one of devices- lucea 10.As it was stated, the suspension arm almost detached from the main tube.There was no injury reported however we decided to report the issue in abundance of caution as such situation may lead to serious injury upon reoccurrence.

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

• 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: 8863642
• MDR Text Key: 170355707
• Report Number: 9710055-2019-00228
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568602971
• Device Catalogue Number: ARD568602971
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1