MAUDE Adverse Event Report: MAQUET SAS LUCEA 10; DEVICE, MEDICAL EXAMINATION, AC POWERED

Catalog Number ARD568602989

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/05/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, getinge became aware of an issue with one of our examination lights ¿ lucea 10.As it was stated the light has fallen.There was no injury reported, however, we decided to report the issue in an abundance of caution as a fall of a device may lead to injury of a patient.

Manufacturer Narrative

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

Manufacturer Narrative

The initial reporter was biomedical.The correction of h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.Getinge became aware of an issue with one of our examination lights ¿ lucea 10.As it was stated the light has fallen.There was no injury reported, however, we decided to report the issue in an abundance of caution as a fall of a device may lead to injury of a patient.Based on an information gathered, the defective coque transparente - lucea 10 (ard368601555) and l10-s/e interface poignee et flexible v2 (ard368606997) were replaced, and the device was returned to the clinical use.Based on the information collected, it was established that when the event occurred, the examination light did not meet its specification, given the headlight detachment, and in this way the device contributed to the event.It remains unknown whether the affected device was or was not being used for patient treatment or diagnosis when the event occurred.When reviewing reportable events for this type of issues we were able to establish that the received incident is occurring at a very low ratio on lucea 10/40.When reviewing similar reportable events for the same device type, it was confirmed that in the last 5 years, registered for the issue of headlight detachment on lucea 10/40 examination lights, there is no event which led to the serious injury.Comparing the number of claimed devices to number of sold devices worldwide, we can assume that the failure ratio for the issue investigated herein is very low.Root cause analysis was performed by subject matter experts at the manufacturing site.As they stated, based on an information provided by technician, the probable root cause of the malfunction is a misuse of the device.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 10
• 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: 15585879
• MDR Text Key: 302787824
• Report Number: 9710055-2022-00417
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/12/2022

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 Catalogue Number: ARD568602989
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 05/24/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1