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

Model Number ARD368605998

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 28th january, 2021 getinge became aware of an issue with lucea 40 light.As it was stated, the spring arm's cover cap was missing.There was no injury reported, however we decided to report the issue in abundance of caution as any parts falling off may cause potential infection.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with lucea 40 light.As it was stated, the spring arm's cover cap was missing.There was no injury reported, however we decided to report the issue in abundance of caution as any parts falling off may cause potential infection.It was established that when the event occurred, the surgical light did not meet its specification as spring arm¿s cover cap was missing and it contributed to the issue.There is no information if in the time of event the device was or was not being used for patient treatment.Subject matter experts conducted the analysis for this case.A picture shows a missing spring arm cover, this cover probably fell due to a collision.To prevent any incident, the instruction for use ifu 01701en06 mentions to perform the daily inspections before use to verify the integrity of the device checking that the device has not suffered any impact damage.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

• 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
• MDR Report Key: 11272442
• MDR Text Key: 230051900
• Report Number: 9710055-2021-00039
• 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,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD368605998
• Device Catalogue Number: ARD368605998
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1