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

Catalog Number ARD568601998

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of our examination lights, lucea 40.As it was stated the handle interface with fork was broken with missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling may lead to potential infection of the patient.

Manufacturer Narrative

Getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated the handle interface with fork was broken with missing particles, what was also confirmed by a photographic evidence.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling may lead to potential infection of the patient.According to the information provided by getinge technician, damaged cover - handle interface with fork - lucea 40 (ard368605998) was replaced and the device was handed back to usage.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 diagnosis purposes.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 which based on internal test done by maquet sas, only abnormal use (violent collisions, excessive pressure¿) or the use of incompatible cleaning products or protocol, can damage this device as reported in this complaint.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.E1 initial reporter: facility team.

Event Description

On 15th september 2022, getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated the handle interface with fork was broken with missing particles, what was also confirmed by a photographic evidence.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling may lead to potential infection of the patient.

• 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: 15518752
• MDR Text Key: 305184034
• Report Number: 9710055-2022-00399
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 09/30/2022

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: ARD568601998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 05/17/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1