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

Model Number ARD568410753A

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.We received the information that two surgical lights are affected therefore two reports are being sent.Other text : device not returned to manufacturer.

Event Description

On (b)(6) 2019 getinge became aware of an issue with one of surgical lights- power led.As it was stated, the plastic cover damage was discovered on light heads.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure might be a source of contamination.

Manufacturer Narrative

The issue is being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights- powerled.As it was stated, some plastic cover damage was discovered on light heads.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure might be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification 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 or worse, to death.The involved zone on the device has visual indications that points to the likeliness of it having been prolongly exposed to cleaning and disinfecting agents.This indicates that cleaning agent residues passed through the painted surfaces and leading to its degradation.The concentration of chemical products, the presence of agent residual on the disinfected surfaces are probably the main factors leading to the deterioration of surfaces.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.Given the circumstances and the fact that there is no apparent trend in complaints of this nature 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: (b)(4).

Manufacturer Narrative

We have found a mistake in wording previously sent in h10 field therefore we are sending the correction.Getinge became aware of an issue with one of surgical lights- powerled.As it was stated, some plastic cover damage was discovered on light heads.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure might be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification 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 or worse, to death.The involved zone on the device has visual indications that points to the likeliness of it having been prolongly exposed to cleaning and disinfecting agents.This indicates that cleaning agent residues passed through the surfaces and leading to its degradation.The concentration of chemical products, the presence of agent residual on the disinfected surfaces are probably the main factors leading to the deterioration of surfaces.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.Given the circumstances and the fact that there is no apparent trend in complaints of this nature 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: (b)(4).

• Brand Name: POWERLED
• 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: 8855035
• MDR Text Key: 174903001
• Report Number: 9710055-2019-00225
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568410753A
• Device Catalogue Number: ARD568410753A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1