MAUDE Adverse Event Report: MAQUET SAS POWERLED II; LAMP, SURGICAL

Model Number ARD569202965

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 11/17/2019

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by manufacturer.Device not returned to manufacturer.

Event Description

On (b)(6) 2019 getinge became aware of an issue with two surgical lights - powerled ii 500 and 700.As it was stated, the lamp beam caused damage of patient¿s skin (burn or lesion) due to too high irradiance.

Event Description

Manufacturer reference number: 268494.

Manufacturer Narrative

Getinge became aware of an incident with surgical light powerled ii device.As it was stated by the customer, the light beam was generating too much heat/irradiance.There was no serious injury reported however, we decided to report the issue in abundance of caution and based on the potential for burns if the situation was to reoccur, as not following user manual may lead to undesirable situations.During investigation it was revealed that device was working according to the manufacturers specification as no actual, technical malfunction occurred.In the time when the event occurred the device was being used for patient treatment and it contributed to incident.When reviewing similar reportable events for the same device, we have been able to confirm that the investigated issue has never led to serious injury or worse.The most probably root cause appears to be a not following manufacturer¿s recommendations, as it is stated in user manual light is a form of energy that can cause tissue to dry, particularly if light beams from more than one lighthead are superimposed.The user must be aware of the risks relating to exposure of open wounds to a light source of too great as intensity.The user must be vigilant and must adjust the level of illumination to suit the patient concerned, particularly during a lengthy procedure.Non-compliance with the specified terms of use is considered as user error.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: POWERLED II
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 9368763
• MDR Text Key: 178198901
• Report Number: 9710055-2019-00337
• Device Sequence Number: 1
• Product Code: FTD
• 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
• Report Date: 03/26/2020

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: No Information
• Device Model Number: ARD569202965
• Device Catalogue Number: ARD569201965 AND ARD569202965
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other