MAUDE Adverse Event Report: MAQUET SAS LUCEA 10/40; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number ARD568601998

Device Problems Break (1069); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

On 17th october, 2023 getinge became aware of an issue with one of our examination lights ¿ lucea 40.It was stated the transparent cover (ard368606555) on the fasteners had completely broken off.The user had to attach it with adhesive tape, otherwise the cover would have fallen off.Photographic evidence confirmed that issue and also indicated that some particles from cover and tape were missing.There was no injury reported, however we decided to report the issue in abundance of caution as any parts or 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.(b)(6).H3 other text: device not returned to manufacturer.

Manufacturer Narrative

Getinge became aware of an issue with one of our examination lights ¿ lucea 40.It was stated the transparent cover (ard368606555) on the fasteners had completely broken off.The user had to attach it with adhesive tape, otherwise the cover would have fallen off.Photographic evidence confirmed that issue and also indicated that some particles from cover and tape were missing.There was no injury reported, however we decided to report the issue in abundance of caution as any parts or particles falling off during examination may lead to potential infection of the patient.It was established that when the event occurred, the examination light did not meet its specification due to cracks and missing particles from cover, which contributed to the event.Provided information indicate that upon the event occurrence the device was not being used for patient treatment.Review of received customer product complaints related to investigated issue, revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.We can assume that the failure ratio of cracks and missing particles on lucea 10/40 devices is moderate.A root cause analysis was performed by subject matter experts at manufacturing site.Based on some internal test done by maquet sas (ref: cre 12-085 for instance), 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.Tests performed by getinge did not lead to cracks as reported in the complaint at hand.The cracks detected on the handle interface and transparent cover fixing points were probably caused by improper use, collisions, incompatible cleaning products or protocol.To prevent any incident the lucea10/40 instruction for use 01701 en12 mentions to check the integrity of the light heads during daily inspection and describes how to clean and disinfect the light head.This document includes some recommended products and some prohibited products.In order to avoid mechanical stresses applied on the transparent housing during use the lucea10/40 instruction for use 01701 en12 mentions to handle the light head by the handle.To prevent any incident the lucea10/40 instruction for use ifu 01701 mentions to check the integrity of the light heads during daily inspection.Furthermore the lucea10/40 instruction for use ifu 01701 en12 explains how to clean and disinfect the light heads.This document includes some recommended products and some prohibited products.In order to avoid torques applied on the transparent housing during use the lucea10/40 instruction for use ifu 01701 en12 mentions to handle the light head by the handle (ifu_lucea_10_40_01701en12, pages 22-25, 30).We believe the related devices are performing correctly in the market.We also believe that if the manufacturer 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.

Event Description

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

• Brand Name: LUCEA 10/40
• 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: 17975635
• MDR Text Key: 326824476
• Report Number: 9710055-2023-00789
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568601998
• Device Catalogue Number: ARD568601998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1