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

Model Number ARD569089999

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of examination lights - lucea 40.It was stated the headlight was broken with potential of missing particles.We decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated the headlight was broken with potential of missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause contamination.The affected device was repaired by replacing the broken part (ard568601997 - lighthead lucea 40).It was established that when the event occurred, the examination light did not meet its specification due to cracks and missing particles from covers, 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 cracks and missing particles 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_11, pages 28-29).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 21 of nu_01701en_11).We believe the related devices are performing correctly in the market.We also believe that if the manufacturer 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.The correction of b3 date of event and b5 describe event or problem fields deems required due to the update of aware date.This is based on the internal evaluation.Previous b5 describe event or problem: on 21st january, 2023 getinge became aware of an issue with one of examination lights - lucea 40.It was stated the headlight was broken with potential of missing particles.We decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause contamination.Corrected b5 describe event or problem: on 20th february, 2023 getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated the headlight was broken with potential of missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause contamination.Previous b3 date of event: 02/21/2023.Corrected b3 date of event: n/a.

Event Description

On 20th february, 2023 getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated the headlight was broken with potential of missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause contamination.

• 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: 16590810
• MDR Text Key: 311781893
• Report Number: 9710055-2023-00241
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD569089999
• Device Catalogue Number: ARD569089999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1