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

Model Number ARD568601998

Device Problems Corroded (1131); Fluid/Blood Leak (1250)

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

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

The initial reporter: (b)(6).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 the one of surgical light - lucea 40.It was stated the water was dripping and rusty liquid was flowed out from the arm of the light.We decided to report the issue in abundance of caution as water inside the lighthead may lead to significant overheating of the device and the rusty liquid falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 4th august, 2022 getinge became aware of an issue with the one of surgical light - lucea 40.It was stated the water was dripping and rusty liquid was flowed out from the arm of the light.We decided to report the issue in abundance of caution as water inside the lighthead may lead to significant overheating of the device and the rusty liquid falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: getinge became aware of an issue with the one of examination lights - lucea 40.It was stated the water was dripping and rusty liquid flowed out from the arm of the light.We decided to report the issue in abundance of caution as water inside the lighthead may lead to rusty liquid falling off into examination field or during procedure may cause contamination.According to the service report attached by getinge technician, after the visit the device was handed over to the customer in good working condition.As also communicated by the technician, the cause of leakage is customer¿s air conditioning unit, which subsequently contributed to the rust occurrence.It was established that when the event occurred, the surgical light did not meet its specification due to rust liquid dripping from the device, which as a result contributed to the event.Provided information do indicate if upon the event occurrence, the device was or 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.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio of occurrence is very low.As stated by the subject matter expert at manufacturing site, there is very few information available provided by the service unit to the record investigated herein.The probable root cause of the presence rusty water on the spring arm is due to water infiltration across from the suspension.What is worth highlighting, particular attention should be taken of this configuration over time (risk of rust appearing in the suspension and spring arm, risk of seizure and corrosion).Subject matter expert also reminded that fumigation methods are unsuitable for disinfecting the unit and shall not be used (ifu lucea 10/40 01701 en 11, page 28).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.

Event Description

On 4th august, 2022 getinge became aware of an issue with the one of examination lights - lucea 40.It was stated the water was dripping and rusty liquid flowed out from the arm of the light.We decided to report the issue in abundance of caution as water inside the lighthead may lead to rusty liquid falling off into examination field or during procedure may cause contamination.

• 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: 15208438
• MDR Text Key: 302795490
• Report Number: 9710055-2022-00337
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• 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: 08/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1