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

Model Number ARDLCA109001C

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.Device not returned to manufacturer.

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.According to initially provided information, the device has lost its anchor point.There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of any parts or configuration could lead to serious injury.

Event Description

On 15th july, 2022 getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated, the headlight has lost its anchor point.There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of headlight could lead to serious injury.

Manufacturer Narrative

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.The correction of b5 describe event or problem, d1 brand name, d2a product code, d2b common device name, d4 version or model # fields deems required.This is based on the additional information that has been received.Previous b5 describe event or problem: on 15th july, 2022 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.According to initally provided information, the device has lost its anchor point.There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of any parts or configuration could lead to serious injury.Corrected b5 describe event or problem: on 15th july, 2022 getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated, the headlight has lost its anchor point.There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of headlight could lead to serious injury.Previous d1 brand name: powerled ii.Corrected d1 brand name: lucea 40.Previous d2a product code: ftd.Corrected d2a product code: kzf.Previous d4 version or model #: ardpwt209050a.Corrected d4 version or model #: ardlca109001c.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated, the headlight has lost its anchor point.There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of headlight could lead to serious injury.Based on the service report provided by getinge technician, the affected device was repaired and put back to service.It was established that when the event occurred, the surgical light did not meet its specification due to lost anchor point, which contributed to the event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing similar reportable events for the same device type, it was confirmed that in the last 5 years, registered for the issue of lost anchor point on lucea 10/40 lights, there are no events which led to the serious injury or worse.Comparing the number of claimed devices to number of sold devices worldwide, we can assume that the failure ratio of this issue is very low.A root cause analysis of the issue investigated herein was brought for further review by subject matter experts at manufacturing site.Unfortunately, maquet sas 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 can not be performed.In case of new relevant information, the case will be reconsidered.We believe the related devices are performing correctly in the market.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: 15128344
• MDR Text Key: 303909866
• Report Number: 9710055-2022-00309
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDLCA109001C
• Device Catalogue Number: ARDLCA109001C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1