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

Model Number ARD515076999

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 19th january, 2021 getinge became aware of an issue with maquet sas surgical light.As it was stated, the electrical panel was not grounded.There was no injury reported, however, we decided to report the issue based on the potential for the injury as lack of grounding is creating risk of electrical shock for operator of the device.

Manufacturer Narrative

On (b)(6) 2021 getinge became aware of an issue with hled surgical light.As it was stated, the electrical panel was not grounded.There was no injury reported, however, we decided to report the issue based on the potential for the injury as lack of grounding is creating risk of electrical shock for operator of the device.It was established that when the event occurred, the surgical light did not meet its specification as lack of grounding occurred and it contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.Unfortunately, manufacturer did not receive enough information to conduct the technical investigation.It is not possible to determine the root cause nor provide the most probable root causes.In case of new relevant information, the case will be reconsidered.We believe that all remaining devices are performing correctly in the market.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.The correction of d1 brand name field deems required.This is based on the information obtained from the service unit.Previous d1 brand name: surgical light.Corrected d1 brand name: hled.

Event Description

Manfuacturer's reference number (b)(4).

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The purpose of this submission is solely to provide a correction of g4: date received by manufacturer section provided in the initial report.This is based on the invofrmation provided by the service unit.#g4: previous date received by manufacturer: 2020-01-19.Corrected date received by manufacturer: 2021-01-19.

Event Description

Manufacturer reference number (b)(4).

Event Description

Manfuacturer's reference number (b)(4).

Manufacturer Narrative

Further to the conclusion which was submitted with 2nd follow up report 9710055-2021-00025 (manufacturer's reference number (b)(4)), 3rd follow up report is submitted to complement the investigation.Further evaluation was performed concluding the lack of earth connections observed for this installed hled configuration is clearly a noncompliance with recommendations and warnings mentioned in our installation manuals.The installation was not carried out by getinge.The customer was communicated with, regarding the fact the installation is what caused the issue.During the investigation it was confirmed the issue of not turning all leds on and the problem with lack of grounding were not related to each other.Therefore, taking under consideration all obtained data, the issue related to not working leds is not considered as risk related.We believe that all remaining devices are performing correctly in the market.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: HLED
• 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: 11228447
• MDR Text Key: 228637791
• Report Number: 9710055-2021-00025
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD515076999
• Device Catalogue Number: ARD515076999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1