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

Catalog Number ARD568350902

Device Problem Temperature Problem (3022)

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

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is still investigated by manufacturing site.Other text : device not returned to manufacturer.

Event Description

On (b)(6) 2019 getinge became aware of an issue with one of surgical lights ¿ powerled.As it was stated, the light was getting hot.There was no injury reported however we decided to report the issue based on the potential as the issue may lead to the injury.

Manufacturer Narrative

The issue is still 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).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with a surgical light ¿ powerled.As it was stated, the light was getting hot.There was no injury reported however we decided to report the issue based on the potential as the issue may lead to the injury.It was established that when the event occurred, the surgical light met its specification and it contributed to the event.None of information available to date suggest that at the time when the event occurred the device was being used for the patient treatment.Based on the performed investigation and with the limited information received it seems that the event may have been related to subjective feeling of the user.This could be confirmed by the service technician¿s statement that he did not found any technical malfunction or abnormalities during the check.Per the user manual, the manufacturer recommends to properly set the illumination level for each operation and patient.We believe that this type of our 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.

• Brand Name: POWERLED 500
• 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: 9104407
• MDR Text Key: 175200513
• Report Number: 9710055-2019-00275
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ARD568350902
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1