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

Model Number ARD568351939

Device Problem Temperature Problem (3022)

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

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.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 very hot.There was no injury reported however we decided to report the issue in abundance of caution as excessive heat produced by light might lead to serious injury.

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

Getinge became aware of an issue with a surgical light powerled device.The allegation received was pointing to light being very hot.There was no injury reported however we decided to report the issue in abundance of caution as excessive heat produced by light might theoretically lead to serious injury.It was established that when the event occurred, the surgical light met its specification and it contributed to the event.Upon the event occurrence the device was not being used for patient treatment.The feedback received was subjective.To more thoroughly investigate the manufacturer suggests to use a specified tool for the measurement and the required settings and parameters, however the technician was not able to duplicate the issue.It is worth noting that powerled user manual includes a warning to set the appropriate illumination levels for each operation and patients to prevent any adverse outcome from occurring.Based on the performed investigation and with the limited information received we were not able to conclude an actual root cause that has led to the event occurrence.We did however confirm that involved device was working correctly and no malfunction was found with the unit.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: 8878448
• MDR Text Key: 153857790
• Report Number: 9710055-2019-00247
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568351939
• Device Catalogue Number: ARD568351939
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1