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

Model Number ARD568601997

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2021 getinge became aware of an issue with lucea 40 light.As it was stated, the headlight cover was cracked.Photographic evidence showed that there were missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with examination light ¿ lucea 40.As it was stated, the headlight cover was cracked.Photographic evidence showed that there were missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.It was established that when the event occurred, the light did not meet its specification as the cover was damaged and particles were missing and it contributed to event.The device was not being used for patient diagnosis or treatment when event occurred.The cracks detected on headlight cover were probably caused by the incompatibility of the cleaning protocol or an abnormal use.The user manual 01701 en 10 page 27 ¿ 29 describes how to clean and disinfect the light heads.This document includes some recommended products and some prohibited products.In order to avoid mechanical stresses applied on the transparent housing during use, ifu 01701 en 10 page 23-24 mentions to handle the light head by the handle.The cleaning and handling tests performed by getinge (ref.Cre 12-085) did not lead to cracks as reported in the complaints.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

Event Description

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

• 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: 12505781
• MDR Text Key: 272450612
• Report Number: 9710055-2021-00305
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568601997
• Device Catalogue Number: ARD568601997
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/29/2021
• Patient Sequence Number: 1