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

Device Problem Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

On 2nd june, 2021 getinge became aware of an issue with led surgical light.The dust was falling from the surgical light.We are not aware of any injury this has caused however we decided to report the issue based on the potential as fall of any dirt may cause risk of contamination of sterile field.

Manufacturer Narrative

Getinge became aware of an issue with hled surgical light.The dust was falling from the surgical light.We are not aware of any injury this has caused however we decided to report the issue based on the potential as fall of any dust may cause risk of contamination of sterile field.It was established that when the event occurred, the surgical light meet its specification, due to dust coming from hospital infrastructure.There is no information if the device was or was not being used for patient treatment at the time when the event occurred.During the investigation, it was found that the reported scenario has never led, to date, to serious injury or worse.Ssu informed us that the equipment was checked and it was found that it was dust from the hospital infrastructure.It's the result of a lack of cleaning, it is a phenomenon external to the device.This problem is not related to the device.The device was cleaned and tests were performed.Equipment was released for use.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

Event Description

Manufacturer reference number (b)(4).

• 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: 11998052
• MDR Text Key: 256169421
• Report Number: 9710055-2021-00218
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/24/2021
• Patient Sequence Number: 1