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

Model 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 9th of june 2020 getinge became aware of an issue with one of the light ¿ lucea 40.As it was stated the plastic casing of the lucea was broken.No information about any parts falling down was provided however we decided to report this case in abundance of caution as the issue might have led to detachment of particles and consequently as potential risk.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 the light ¿ lucea 40.As it was stated the plastic casing of the lucea was broken.No information about any parts falling down was provided however we decided to report this case in abundance of caution as the issue might have led to detachment of particles and consequently as potential risk.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.

• Brand Name: LUCEA
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• MDR Report Key: 10147220
• MDR Text Key: 195016615
• Report Number: 9710055-2020-00174
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568601997
• Device Catalogue Number: ARD568601997
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1