MAUDE Adverse Event Report: MAQUET SAS HLED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568357999

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.Other text : device not returned to manufacturer.

Event Description

On (b)(6) 2020 getinge became aware of an issue with hled surgical light.As it was stated, the light head was so overheated that it was impossible to clean it.There was no injury reported, however we decided to report the issue in abundance of caution as overheating of light head may lead to serious injury.

Manufacturer Narrative

Getinge became aware of an issue with hled surgical light.As it was stated, the light head was so overheated that it was impossible to clean it.There was no injury reported, however we decided to report the issue in abundance of caution as overheating of light head may lead to serious injury.It was established that when the event occurred, the light head met its specification however it contributed to the event.At the time when the event occurred the device was not being used for patient treatment.The issue was investigated by a subject matter expert.It was found that the customer feedback received was subjective and could not be reproduced and objectively measured.We concluded that the issue could be related to subjective feeling of the user.Given the circumstances and the fact that there is no apparent trend in the complaints we 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 ot289780.

• Brand Name: HLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 9675895
• MDR Text Key: 179264254
• Report Number: 9710055-2020-00011
• Device Sequence Number: 1
• Product Code: FSY
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568357999
• Device Catalogue Number: ARD568357999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1