MAUDE Adverse Event Report: MAQUET SAS LUCEA 100; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD2LCA0005

Device Problems Mechanical Problem (1384); 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 (b)(6) 2021 getinge became aware of an issue with lucea 100 surgical light.As it was stated, the wall-mounted light comes off the wall bracket.There was no injury reported.We decided to report the issue based on the potential as this kind of malfunction may lead to detachment of the light and then to serious injury or worse.

Manufacturer Narrative

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

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with lucea 100 surgical light.As it was stated, the wall-mounted light comes off the wall bracket.There was no injury reported.We decided to report the issue based on the potential as this kind of malfunction may lead to detachment of the light and then to serious injury or worse.It was established that when the event occurred, the surgical light did not meet its specification as the device should not come off the wall, and it contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.The most probable root cause of this incident is a wrong installation, not performed according to the recommendations and rules given in both installation manual and installation recommendations manual of this light.There may be several reasons as: wrong dowels used in the concrete wall.The system (wall box) was not tight enough.The back plate was not installed.The other probable reason could be also a weight overload applied on the main arm.We believe that overall the devices on the market are performing correctly.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: LUCEA 100
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11347957
• MDR Text Key: 232527418
• Report Number: 9710055-2021-00064
• Device Sequence Number: 1
• Product Code: FSY
• 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: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD2LCA0005
• Device Catalogue Number: ARD2LCA0005
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1