MAUDE Adverse Event Report: MAQUET SAS LUCEA 50; LAMP, SURGICAL

Model Number ARDLCA209012A

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by manufacturing site.

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of surgical lights - lucea 50.As it was stated, the electrical connection in a spring arm was faulty creating sparkling sound.There was no injury reported however we decided to report the issue basing on a potential as faulty electrical connection may lead to electrical shock of operator of the device.

Manufacturer Narrative

Issue is being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The correction of b5.Describe event or problem deems required.This is based on the information provided by the service unit.Previous b5.Describe event or problem: on 12th august, 2020 getinge became aware of an issue with one of surgical lights - lucea 50.As it was stated, the electrical connection in a spring arm was faulty creating sparkling sound.There was no injury reported however we decided to report the issue basing on a potential as faulty electrical connection may lead to electrical shock of operator of the device.Corrected b5.Describe event or problem: on 13th august, 2020 getinge became aware of an issue with one of surgical lights - lucea 50.As it was stated, the electrical connection in a spring arm was faulty creating sparkling sound.There was no injury reported however we decided to report the issue basing on a potential as faulty electrical connection may lead to electrical shock of operator of the device.

Event Description

On 13th august, 2020 getinge became aware of an issue with one of surgical lights - lucea 50.As it was stated, the electrical connection in a spring arm was faulty creating sparkling sound.There was no injury reported however we decided to report the issue basing on a potential as faulty electrical connection may lead to electrical shock of operator of the device.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - lucea 50.As it was stated, the electrical connection in a spring arm was faulty creating sparkling sound.There was no injury reported however we decided to report the issue basing on a potential as faulty electrical connection may lead to electrical shock of operator of the device.According to the service technician, the issue has been solved by replacement of the affected spring arm.It was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification and it contributed to the event.It is unknown if the device was being used for patient treatment when the issue occurred.Taking into consideration the install base for lucea 50/100 surgical lights, comparing to the number of complained devices, the failure ratio is very low.Subject matter expert has investigated the issue.The failure of the lucea 50 was caused by the deterioration of the cable located in the spring arm.The probable causes of the deterioration of the cable are listed below: -during assembly in production, the insulation of the cable passing inside the spring arm tube has been cut by friction against a sharp part of the tube.- during assembly in production, the cable has been misplaced at the level of the rotation axis and during up/down movement of the spring arm the cable insulation has been damaged.To prevent any incident, the 24 vdc supply voltage used to power the light head reduces the risk of electric shocks, moreover circuit breakers and grounding installations protect the users against electric shocks.The lucea 50/100 installation manual 01744 mentions : ¿a fault on the protective earth connection of the metal parts may eliminate the protection against electrical shocks in the event of a fault.To avoid any risk of an electric shock, class i devices must be connected to a power supply system which is earthed¿.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 reference number (b)(4).

• Brand Name: LUCEA 50
• Type of Device: LAMP, SURGICAL
• 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: 10419204
• MDR Text Key: 203306786
• Report Number: 9710055-2020-00321
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARDLCA209012A
• Device Catalogue Number: ARDLCA209012A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1