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

Model Number ARD568601998

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

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

Event Date 12/12/2022

Event Type  malfunction  

Event Description

On (b)(6)2022 getinge became aware of an issue with one of examination lights - lucea 40.It was stated the cover was cracked with missing particles.We decided to report the issue in abundance of caution as any parts falling off during examination procedure may cause contamination.

Manufacturer Narrative

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

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of examination lights - lucea 40.It was stated the cover was cracked with missing particles.We decided to report the issue in abundance of caution as any parts falling off during examination procedure may cause contamination.According to the information provided by getinge technician, damaged cover 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 indicate that upon the event occurrence, the device was 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, the probable causes of the breakage are the collisions or abnormal use.The cleaning and handling tests cre 12-085 performed by getinge did not lead to cracks as reported in this complaint.Based on this test, the most probable causes leading to the handle interface cracks is an improper uses and collisions.To prevent any incident the lucea10/40 instruction for use ifu 01701 en 12 on page 22 mentions: to check that the device has not suffered any impact damage.To check for any chipped or missing paint.Also the following warning is mentioned on page 20 of the same ifu: ¿warning! risk of injury/infection.The use of a damaged device may lead to a risk of injury for users or a risk of infection for patients.Do not use a damaged device.¿ 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 d4 serial # field deems required.This is based on the internal evaluation.Previous d4 serial #(b)(6).Corrected d4 serial #(b)(6).

• 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: 15994420
• MDR Text Key: 305720474
• Report Number: 9710055-2022-00523
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ARD568601998
• Device Catalogue Number: ARD568601998
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1