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

Model Number ARD568371939

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

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 water was dripping from light head while the patient was on table.There was no injury reported however we decided to report the issue in abundance of caution as water leak through the device on the operating table may lead to the contamination of sterile field.

Event Description

Manufacturer reference number ot293779.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - powerled.As it was stated, the water was dripping from light head while the patient was on table.There was no injury reported however we decided to report the issue in abundance of caution as water leak through the device on the operating table may lead to the contamination of sterile field.It was established that when the event occurred, the device met its specification and it contributed to the event.At the time when the event occurred the device was being used for the patient treatment.The issue was investigated by a subject matter expert.The root cause of the presence of water in the cupola is due to water infiltration across from the suspension and spring arm as the problem with false ceiling occurred on the facility.Given the circumstances and the fact that it is single and isolated event 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
• 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: 9719801
• MDR Text Key: 181807081
• Report Number: 9710055-2020-00015
• 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,user f
• 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: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568371939
• Device Catalogue Number: ARD568371939
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1