MAUDE Adverse Event Report: MAQUET SAS LUCEA; LIGHT, SURGICAL, FLOOR STANDING

Catalog Number ARD568604999

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by manufacturer.Other text : device not returned to manufacturer.

Event Description

On (b)(6) 2020 getinge became aware of an issue with surgical light ¿ lucea.As it was stated, headlight has hit the main arm or ceiling, resulting in detachment of cover.There was no injury reported however we decided to report the issue in abundance of caution as any falling parts might cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights- lucea 50.As it was stated, the cupola has hit the main arm or ceiling, resulting in detachment of its cover.There was no injury reported however we decided to report the issue in abundance of caution as any falling parts might cause contamination.Based on the performed trend review we conclude that there is no apparent trend for the issue with this device and that this is the fifth complaint of this nature received in the last 5 years.When the event occurred, the device did not meet its specification and it contributed to event.The provided information did not indicate that the device was being used for patient treatment when the event took place.In user manual 01741en05, there is an information included to check the device for impact marks and any other damage.It was established that the most likely root cause could be related to abnormal use (violent collisions, shock with another device) which can damage this device as reported in this complaint we believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: LUCEA
• Type of Device: LIGHT, SURGICAL, FLOOR STANDING
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 9639829
• MDR Text Key: 179262357
• Report Number: 9710055-2020-00009
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD568604999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1