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

Model Number ARD568350933

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2020

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.As it was stated, the light head drifted downwards and hit the surgeon.Moreover, the light head also almost touched the patient while drifting downwards.There was no injury reported however we decided to report the issue in abundance of caution as contact of the light head with the patient or sterile field may lead to the contamination.

Manufacturer Narrative

The issue is still being investigated.Additional information will be provided upon results of investigation.

Event Description

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

Manufacturer Narrative

The issue is being investigated by the manufacturing site.

Event Description

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

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - powerled.As it was stated, the light head drifted downwards and hit the surgeon.Moreover, the light head also almost touched the patient while drifting downwards.There was no injury reported however we decided to report the issue in abundance of caution as contact of the light head with the patient or sterile field may lead to the contamination.It was established that when the event occurred, the surgical light did not meet its specification as the spring arm should remain in established position, and it contributed to event.In the time when the event occurred the device was being used for the patient treatment.The root cause of this incidence is related to two factors: defective spring arm (badly strength of the spring).Incorrect adjustment of spring arm (without tacking the camera).Powerled user manual mentions to check the spring arm remains in position.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.We believe that our devices are performing correctly on the market.

• 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: 9823655
• MDR Text Key: 183254103
• Report Number: 9710055-2020-00036
• 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,Followup,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568350933
• Device Catalogue Number: ARD568350933
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1