MAUDE Adverse Event Report: MAQUET SAS POWERLED II; LAMP, SURGICAL

Model Number ARD569201907

Device Problem Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of surgical lights - powerled ii.As it was stated, customer said that patient had a dark spot on the skin exposed to the surgical light that wasn't there before the case.It was not established what exactly caused the discoloration however we decided to report the issue in abundance of caution as excessive heat from light head may lead to serious injury or worse.

Manufacturer Narrative

Issue is still being investigated by manufacturing site.

Event Description

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

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - powerled ii.As it was stated, customer said that patient had a dark spot on the skin exposed to the surgical light that wasn't there before the case.It was not established what exactly caused the discoloration however we decided to report the issue in abundance of caution as excessive heat from light head may lead to serious injury or worse.During investigation, it was found that device was not according to the manufacturer¿s specification.In the time when the event occurred, the device was being used for patient treatment and it contributed to the event.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.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 can not 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.The purpose of this submission is also to provide a correction of version or model# and catalog# sections.This is based on the result of receiving additional information #d4: previous version or model#: ard268400210a; corrected version or model#: ard569201907; previous catalog#: ard268400210a; corrected catalog#: ard569201907.

• Brand Name: POWERLED II
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 9829252
• MDR Text Key: 183487405
• Report Number: 9710055-2020-00038
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD569201907
• Device Catalogue Number: ARD569201907
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1