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

Catalog Number ARD568601997

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2019 getinge became aware of an issue with one of the light ¿ lucea.As it was stated the plastic casing of the lucea was cracked and due to this was removed from the room.Customer did not provide any information about any parts falling down however on the provided photographic evidence lack of some particles was noticed, therefore we could suspected that some of them potentially fell down.Taking under consideration collected up to date information we decided to report this case based on potential as any parts falling from the device might cause contamination.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The issue is being investigated by the manufacturing site.

Event Description

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

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of examination lights - lucea 40.As it was stated the plastic casing of the lucea was broken and due to this was removed from the room.As it was stated the plastic casing of the lucea was broken and due to this was removed from the room.Photographic evidence of the issue was provided and it was in line with alleged situation.Moreover in some of affected light heads visible lack of particles was noted.Based on this evidence we could suspected that break of plastic casing could led to missing particles which could further fell down.In general any parts falling down during procedure could led to contamination, therefore even in case at hand no information about any parts falling down was provided we decided to report this case in abundance of caution and based on potential as any parts falling from the device might cause contamination.It was established that when the event occurred, the surgical light did not meet its specification as broken chasing could be considered as technical deficiency of the device 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 led 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.

• 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: 9886509
• MDR Text Key: 187256947
• Report Number: 9710055-2020-00068
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ARD568601997
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1