MAUDE Adverse Event Report: MAQUET SAS LUCEA 100; LAMP, SURGICAL

Model Number ARD568603999

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of our light - lucea 100.As stated top and bottom covers were cracked and damaged and also missing particles were noticed.No information about patient involvement was provided however we decided to report this case in abundance of caution and based on potential as any particles falling into the sterile field might be a source of contamination.Manufacturer's reference number (b)(4).

Manufacturer Narrative

Additional information will be provided upon results of investigation.

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 our devices ¿ lucea 100.The provided problem description included a statement for damaged top and bottom covers.Additionally a cracked covers with missing parts were identified.Fortunately, no injury has been reported due to mentioned issue however we decided to report it based on the potential as such damage could have led to particles detachment, which consequently might become a source of contamination of the sterile field.It was established that when the event occurred, the surgical light did not meet its specification as it was damaged and particles were missing, 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: mechanical stress, environmental conditions (such a high temperature and humidity variations during transport and storage), use of inappropriate cleaning/disinfections products, 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 100
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10507491
• MDR Text Key: 206315512
• Report Number: 9710055-2020-00362
• Device Sequence Number: 1
• Product Code: FTD
• 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: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568603999
• Device Catalogue Number: ARD568603999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 09/18/2020; 11/05/2020
• Supplement Dates FDA Received: 10/14/2020; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1