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

Model Number ARD568601999

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/07/2022

Event Type  malfunction  

Event Description

On (b)(6)2022 getinge became aware of an issue with one of examination lights - lucea 40.It was stated the cover dropped from the headlight.We decided to report the issue in abundance of caution as any parts falling off during examination procedure may cause contamination.

Manufacturer Narrative

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

Manufacturer Narrative

Getinge became aware of an issue with one of examination lights - lucea 40.It was stated the cover dropped from the headlight.We decided to report the issue in abundance of caution as any parts falling off during examination procedure may cause contamination.It was established that when the event occurred, the examination light did not meet its specification due to detachment of cover, which contributed to the event.Provided information does not indicate if upon the event occurrence the device was or was not being used for patient treatment.Review of received customer product complaints related to investigated issue, revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.We can assume that the failure ratio of detachment of cover on lucea 10/40 devices is moderate.As stated by subject matter expert at manufacturing site, cracks were detected at the edge of fixing holes of transparent housing and handle interface were probably caused by the incompatibility of the cleaning protocol or an abnormal use.User manual for lucea 10/40 describes how to clean and disinfect the light heads (nu_01701en_12, pages 29-30).This document includes some of the recommended and prohibited products.In order to avoid mechanical stresses applied on the transparent housing during use the user manual mentions to handle the light by the handle.To prevent similar event, the same user manual mentions to check the light heads during daily inspection (page 22 of nu_01701en_12).We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

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
• 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: 15948484
• MDR Text Key: 305719201
• Report Number: 9710055-2022-00511
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568601999
• Device Catalogue Number: ARD568601999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1