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

Catalog Number ARD568601999

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by manufacturer.Device not returned to manufacturer.

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of examination lights - (b)(6).The subject of the complaint is that the cover of the lamp has cracked and there were missing particles.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.

Manufacturer Narrative

The issue is being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with a lucea device.As it was stated, cracks on the cover of the light have been found.There was no injury reported however we decided to report the issue based on the potential related to parts falling into the sterile field, which may be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.Cover cracking is indicated by our product experts to likely be caused by combination of different factors such as: abnormal use or inappropriate cleaning and disinfection protocols.We believe that all remaining devices are performing correctly in the market.We also believe that if the preventive maintenance would have been followed the incident could have been avoided.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.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: LUCEA
• 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: 9865523
• MDR Text Key: 184474055
• Report Number: 9710055-2020-00041
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD568601999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1