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

Model Number ARDLCA109001A

Device Problems Detachment of Device or Device Component (2907); Installation-Related Problem (2965)

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

Event Date 02/22/2023

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 our examination lights - lucea 40.As it was stated, connection to the wall was loose.There was no injury reported, however, we decided to report the issue in abundance of caution as loose connection holding the device configuration may lead to the device detachment from the wall and serious injury.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of our examination lights - lucea 40.As it was stated, connection to the wall was loose.There was no injury reported, however, we decided to report the issue in abundance of caution as loose connection holding the device configuration may lead to the device detachment from the wall and serious injury.Based on the information collected, it was established that when the event occurred, the examination light did not meet its specification, since loosened connection to a wall could be considered as technical deficiency, and in this way the device contributed to the event.The provided information does not indicate if upon the event occurrence the device was or was not being used for diagnosis purposes.When reviewing reportable events for this type of issue we were able to establish that the received incidents are occurring at a very low ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.According to the analysis performed by the subject matter expert the most probable root cause of this incident corresponds to an anchoring issue performed during the installation, not performed according to the recommendations given by the installation manual.There may be several reasons as: wrong dowels used in the wall.The system (wall box) was not tight enough.The back plate was not installed.The other probable cause could be also a weight overload applied on the device.The lucea installation manual (01704 rev.7, pages 58-59) describes the recommendations regarding the installation of a wall mounted version.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.

• 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: 16512335
• MDR Text Key: 311163380
• Report Number: 9710055-2023-00200
• Device Sequence Number: 1
• Product Code: KZF
• UDI-Device Identifier: 03700712415860
• UDI-Public: (01)03700712415860
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

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 Model Number: ARDLCA109001A
• Device Catalogue Number: ARDLCA109001A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 06/07/2023
• Supplement Dates FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1