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

Model Number ARD515076999

Device Problems Electrical /Electronic Property Problem (1198); Peeled/Delaminated (1454)

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 7th january, 2021 getinge became aware of an issue with hled surgical light.As it was stated, the wall power supply was not grounded.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.

Event Description

Manufacturer reference numer (b)(4).

Event Description

On 7th january, 2021 getinge became aware of an issue with hled surgical light.As it was stated, the wall power supply was not grounded.Moreover, the photographic evidence was showing paint peeling.There was no injury reported, however, we decided to report the issue based on the potential as lack of grounding is creating the risk of electrical shock for operator of the device, moreover, paint particles falling into sterile field are creating the risk of contamination.Manufacturer's reference number (b)(4).

Manufacturer Narrative

On 7th january, 2021 getinge became aware of an issue with hled surgical light.The wall power supply was not grounded.Moreover, the photographic evidence was showing paint peeling.There was no injury reported, however, we decided to report the issue based on the potential as lack of grounding is creating the risk of electrical shock for operator of the device, paint particles falling into sterile field are creating the risk of contamination.It was established that when the event occurred, the surgical light did not meet its specification as lack of grounding and paint peeling 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.All maquet sas products comply with: ¿ iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.¿ iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.¿ paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.¿ disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use) or improper cleaning methodology.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.The correction of b5.Describe event or problem field deem required.This is based on the information provided by service unit.Corrected b5.Describe event or problem on 7th january, 2021 getinge became aware of an issue with hled surgical light.As it was stated, the wall power supply was not grounded.Moreover, the photographic evidence was showing paint peeling.There was no injury reported, however, we decided to report the issue based on the potential as lack of grounding is creating the risk of electrical shock for operator of the device, moreover, paint particles falling into sterile field are creating the risk of contamination.Previous b5.Describe event or problem on 7th january, 2021 getinge became aware of an issue with hled surgical light.As it was stated, the wall power supply was not grounded.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.

• 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: 11163657
• MDR Text Key: 226655628
• Report Number: 9710055-2021-00009
• 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: 01/13/2021
• 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: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1