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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by manufacturing site.It was observed during an external audit at getinge (b)(4), that servicing practices at getinge (b)(4) are not in compliance to applicable requirements due to identified gaps in quality management system.Specifically, unanticipated repair activities were not submitted as complaints and assessed for reporting as required per regulations and as a result this report was not submitted in a timely manner.Getinge (b)(4) has approved a comprehensive remediation plan and all unanticipated repair activities will be submitted as complaints.Device not returned to manufacturer.

Event Description

On 13th august, 2019 getinge became aware of an issue with one of surgical lights - lucea.As it was stated, the support screw was missing.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

On (b)(6) 2019 getinge became aware of an issue with one of surgical lights: lucea.As it was stated, the support screw was missing.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.It was established that when the event occurred, the surgical light did not meet its specification as a part was missing, and it contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury nor death.Unfortunately, manufacturer 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.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
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10367509
• MDR Text Key: 202060247
• Report Number: 9710055-2020-00263
• Device Sequence Number: 1
• Product Code: FTD
• 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
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1