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

Model Number ARD568601997

Device Problem Crack (1135)

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

Event Date 09/07/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 7th september, 2022 getinge became aware of an issue with one of examination lights - lucea 40.It was stated.The light cover was broken with missing particles due to physical damage.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 light cover was broken with missing particles due to impact damage.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.According to the information provided by getinge technician, the affected device was repaired by parts replacement and returned to use after passing functionality tests.Based on the information collected, it was established that when the event occurred, the examination light did not meet its specification, since cracks in covers, resulting in missing plastic particles 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 patient treatment.When reviewing reportable events for this type of issue we were able to establish that the received incidents are occurring at a moderate 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 probable causes of the breakage are the incompatibility of the cleaning products or abnormal use.Based on information provided by getinge technician, it was confirmed that lighthead cover was broken due to impact damage.Maquet sas recommends visual inspection before use according to the user manual (ifu 01701 rev.11, page 21).A daily inspection performed by the user (chipped paint, impact marks and any other damage) will help preventing such event.Maquet sas recommends to inform the customers about the hazards in cases of non-compliance of these instructions.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.The correction of h4 device manufacture date field deems required.This is based on the internal evaluation.Previous h4 device manufacture date: 11/13/2019.Corrected h4 device manufacture date: 11/15/2019.

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: 15417486
• MDR Text Key: 299868706
• Report Number: 9710055-2022-00372
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568601997
• Device Catalogue Number: ARD568601997
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1