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

Model Number ARD568601998

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

On 16th october, 2023 getinge became aware of an issue with one of our examination lights ¿ lucea 40.It was stated the spring arm cover was missing (part no.Ard568641999).There was no injury reported, however we decided to report the issue in abundance of caution as any parts 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

The initial reporter was getinge technician.Getinge became aware of an issue with one of our examination lights ¿ lucea 40.It was stated the spring arm cover was missing (part no.Ard568641999).There was no injury reported, however we decided to report the issue in abundance of caution as any parts falling off during examination may lead to potential infection of the patient.Device has been repaired and 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 missing cover could be considered as technical deficiency, and in this way the device contributed to the event.The device was not being used for patient treatment upon the event occurrence.According to the information gathered, the issue was discovered by getinge technician during preventive maintenance.When reviewing reportable events for this type of issue we were able to establish that the received incidents are occurring at a very low ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.As stated by subject matter expert at maquet sas, the most probable root cause of the break of this cap is repeated and violent shocks during the use of the device.Another probable root cause is that the cap has been forgotten or deteriorated after a readjustment of the spring arm during the maintenance of medical device.The yearly preventive maintenance program documented in the technical manual for lucea 10/40 (0170201 1k) on page 10 mentions to check the fixing of all caps.The cap must be reinstalled during installation or after the maintenance procedure.Maquet sas strongly advises to check similar devices in the hospital in order to check the presence of all spring arms caps.If a missing cap is noticed, a new one should be ordered as spare parts.(blue 30 / lucea 40-50 : ard569010102) 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 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: 17963759
• MDR Text Key: 326010928
• Report Number: 9710055-2023-00783
• 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: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• 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: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1