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

Model Number ARD568350933

Device Problem Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is still being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On (b)(6) 2019 maquet sas has been contacted by third party service provider and informed about e-mail received from a customer using our device, namely a configuration of surgical lights- powerled.As stated by the customer, the device was used in a plastic theatre and, after a procedure, the patient had blistered like sunburn.We are not aware about any medical intervention that has been required due to patient¿s condition.The customer allegation is pointing to powerled device being too hot when illuminating and causing the situation as described above.

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 being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Getinge has been contacted by third party service provider and informed about e-mail received from a customer using our device, namely a configuration of surgical lights- powerled.As stated by the customer, the device was used in a plastic surgery theatre and, after a procedure, the patient had blistered like sunburn.We are not aware about any medical intervention that has been required due to patient¿s condition.The customer allegation is pointing to powerled device being too hot when illuminating and causing the situation as described above.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.Upon the event occurrence the device was being used for patient treatment.Prolonged exposure combined with the overlapping of 3 light patches can contribute to the inflammation of the skin, if patients have photo sensitive skin.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.It seems that the event may have been caused by the combination of patient¿s individual aspects and the type of surgical procedure that was used with the 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.

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).

• 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: 8775116
• MDR Text Key: 150597148
• Report Number: 9710055-2019-00212
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568350933
• Device Catalogue Number: ARD568350933
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 07/04/2019; 07/04/2019; 07/04/2019; 07/04/2019; 07/04/2019; 11/21/2019
• Supplement Dates FDA Received: 08/02/2019; 08/27/2019; 09/20/2019; 10/17/2019; 11/15/2019; 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other