MAUDE Adverse Event Report: MAQUET SAS LUCEA 50; LIGHT, SURGICAL, FLOOR STANDING

Model Number ARD568604942

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.(b)(6).Device not returned to manufacturer.

Event Description

On 6th may 2022 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, the headlight detached from the device.There was no injury reported, however, we decided to report this case in abundance of caution as detachment of the headlight can lead to serious injury in case of event reoccurrence.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The purpose of this submission is solely to provide a correction of h4 manufacture date and d4 serial #.Previous h4 manufacture date 10/24/2014.Corrected h4 manufacture date 10/29/2014.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, the headlight detached from the device.There was no injury reported, however, we decided to report this case in abundance of caution as detachment of the headlight can lead to serious injury in case of event reoccurrence.It was established that when the event occurred, the surgical light did not meet its specification due to the headlight¿s detachment, which contributed to the event.The provided information does not indicate if upon the event occurrence the device was being used for patient treatment.A review of received customer product complaints related to the investigated issue revealed that there were no injuries to a user nor to a patient or operator when these particular malfunctions occurred.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio is very low for headlight¿s detachment on lucea 50/100.As stated by the subject matter expert at manufacturing site, maquet did not receive enough information to conduct the technical investigation.It is not possible to determine the root cause and therefore the factory investigation report cannot be performed.In case of new relevant information, the case will be reconsidered.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 ot629529.

• Brand Name: LUCEA 50
• Type of Device: LIGHT, SURGICAL, FLOOR STANDING
• 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: 14367114
• MDR Text Key: 291482723
• Report Number: 9710055-2022-00154
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2022

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 Model Number: ARD568604942
• Device Catalogue Number: ARD568604942
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 05/25/2022; 08/17/2022
• Supplement Dates FDA Received: 06/14/2022; 09/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1