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

Model Number ARD568601998

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 04/24/2023

Event Type  malfunction  

Event Description

On 24th april, 2023 getinge became aware of an issue with one of examination equipment - lca 40.It was stated the light handle was broken, based on photographic evidence the cover was broken resulting in missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off during examination may lead to potential infection of the patient.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

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

Manufacturer Narrative

According to the information provided by getinge technician, the affected part was replaced (ard368605998 - handle interface with fork - lucea 40).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 also able to confirm that the issue investigated herein has never led to serious injury or worse.Root cause analysis was performed by subject matter experts at manufacturing site.As they stated, the most likely root cause of this malfunction is a violent rotation of the light head.There was re11-052 test performed which proved that the stop in the lighthead resists to 50 strong rotations and this is compliant to the standard ul60601-1.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: 16902514
• MDR Text Key: 314909869
• Report Number: 9710055-2023-00347
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568601998
• Device Catalogue Number: ARD568601998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/26/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1