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

Catalog Number ARD568601997

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/30/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 30th september, 2022 getinge became aware of an issue with one of examination lights - lucea 40.It was stated the switch was missing from headlight.There was no injury reported, however, we decided to report the issue in abundance of caution as any detachment of part or particles may lead to potential infection of the patient.

Manufacturer Narrative

Getinge became aware of an issue with one of examination lights - lucea 40.It was stated the switch was missing from headlight.There was no injury reported, however, we decided to report the issue in abundance of caution as any detachment of part or particles may lead to potential infection of the patient.Technician informed that temporary repair was accomplished the housing was slightly damaged and replacement of housing is recommended.The light is functional and quote for replacement of the housing was supplied.It was established that when the event occurred, the surgical light did not meet its specification due to the reported defect, which contributed to the reportable situation.Based on information collected it was not possible to establish that the affected device was or was not being used for the patient treatment upon the event occurrence.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Comparing the number of affected devices by the investigated issue to the install base, complaint ratio is very low.As stated by subject matter expert at the manufacturing site, maquet sas did not receive enough information to conduct the technical investigation.Nevertheless the probable causes of the deterioration of the button may be due to collision or excessive effort.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).

Manufacturer Narrative

The correction of h4 manufacture date deems required.This is based on the internal evaluation.Previous h4 manufacture date 02/29/2016.Corrected h4 manufacture date 03/04/2016.According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.

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: 15579477
• MDR Text Key: 304508632
• Report Number: 9710055-2022-00416
• 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,Followup
• Report Date: 10/11/2022

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 Operator: Health Professional
• Device Catalogue Number: ARD568601997
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 10/24/2022; 11/24/2022
• Supplement Dates FDA Received: 11/18/2022; 11/25/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1