MAUDE Adverse Event Report: MAQUET SAS POWERLED 500+ DF K3; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number ARD568350933

Device Problem Defective Device (2588)

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

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue is being investigated by manufacturing site.

Event Description

On (b)(4) 2019 maquet (b)(4) became aware of an issue with one of devices- powerled.As it was stated, the light failed during operation and light which was used to complete the procedure was insufficient to have the confidence.There was no injury reported however we decided to report the issue based on the potential.(b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

(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.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number # (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

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

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number # (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

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

The issue is still investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number # (b)(4).

Event Description

Manufacturer reference number #198600.

Manufacturer Narrative

Getinge became aware of an issue with one of devices- powerled.As it was stated, the light failed during operation and light which was used to complete the procedure was insufficient to have the confidence.There was no injury reported however we decided to report the issue based on the potential.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.In the time when the event occurred the device was being used for the patient treatment.Unfortunately, due to the limited information received from the market, subject matter experts were unable to conduct analysis what is the root cause for this case.The electronic boards were not returned back from the market.To sum up, we assume that the most likely root cause is related to electronic parts wear, however without additional information from customer we are unable to fully confirm the root cause.We believe the related devices are performing correctly in the market.Given the circumstances and the fact that the occurrence rate is considered to be low we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: POWERLED 500+ DF K3
• 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: 8390468
• MDR Text Key: 138217004
• Report Number: 9710055-2019-00058
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD568350933
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 02/21/2019; 02/21/2019; 02/21/2019; 02/21/2019; 02/21/2019; 02/21/2019; 02/21/2019; 02/21/2019; 02/21/2019; 02/21/2019; 01/29/2020
• Supplement Dates FDA Received: 03/29/2019; 04/18/2019; 05/14/2019; 06/07/2019; 07/03/2019; 07/26/2019; 08/20/2019; 09/13/2019; 10/11/2019; 11/05/2019; 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1