MAUDE Adverse Event Report: MAQUET SAS LUCEA 10; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number ARDLCA309008C

Device Problems Corroded (1131); Mechanical Problem (1384); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by the manufacturing site.Other text : device not returned to manufacturer.

Event Description

On (b)(6) 2019 getinge became aware of an issue with lucea 10.As it was stated, mobile light was damaged by customer: cover was missing, parts were rusted, paint was peeling, parts were detached.There was no injury reported however we decided to report the issue in abundance of caution as such damaged lamp was still being in use and might cause contamination and hazardous situation.

Manufacturer Narrative

Issue is still being investigated by the manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Issue is still being investigated by the manufacturing site.

Event Description

Manufacturer reference number: 275733.

Manufacturer Narrative

Getinge became aware of an issue with lucea 10.As it was stated, mobile light was damaged by customer: cover was missing, parts were rusted, paint was peeling, parts were detached.There was no injury reported however we decided to report the issue in abundance of caution as such damaged lamp was still being in use and might cause contamination and hazardous situation.It was established that when the issue occurred, the light head did not meet its specification and it contributed to the complaint.In the time when the issue occurred the device was not being used for patient treatment.During the investigation it was found that the issue is single, isolated event and that the reported malfunction has not led to serious injury or worse.We conclude that the issue is most likely caused by wrong maintenance of the device.This defect is visually detectable during the inspection performed by the users before any surgical procedure.We believe the related devices are performing correctly in the market.

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: LUCEA 10
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 9488362
• MDR Text Key: 179256480
• Report Number: 9710055-2019-00364
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARDLCA309008C
• Device Catalogue Number: ARDLCA309008C
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1