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

Model Number 567910968

Device Problem Grounding Malfunction (1271)

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.

Event Description

On (b)(6) 2021 getinge became aware of an issue with one of surgical lights.Inspection performed by the getinge technician revealed lack of grounding on the device.There was no injury reported, however, we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The correction of d1 brand name deems required.This is based on the information provided from the service unit.Previous d1 brand name: surgical light.Corrected d1 brand name: hled.

Event Description

Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 27th january, 2021 getinge became aware of an issue with one of surgical lights.Inspection performed by the getinge technician revealed lack of grounding on the device.There was no injury reported, however, we decided to report the issue based on the potential 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.The lack of earth connections observed for some installed hled configurations 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.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.

Event Description

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

• 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: 11262958
• MDR Text Key: 230980454
• Report Number: 9710055-2021-00035
• 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
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 567910968
• Device Catalogue Number: 567910968
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1