MAUDE Adverse Event Report: MAQUET SAS LUCEA 100; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number ARD568603999

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2018

Event Type  malfunction  

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 during daily checkup of the device.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: 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.Device not returned to manufacturer.

Event Description

On (b)(6) 2018 maquet sas became aware of an issue with one of surgical lights- lucea 100.As it was stated, the cupola was damaged.There was no injury reported however we decided to report the issue in abundance of caution as any part falling may lead to contamination.Manufacturer reference number (b)(4).

• Brand Name: LUCEA 100
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 9982835
• MDR Text Key: 189920014
• Report Number: 9710055-2020-00090
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2020

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: No Information
• Device Model Number: ARD568603999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 04/21/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1