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

Device Problems Crack (1135); Grounding Malfunction (1271)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.It was observed during an external audit at getinge (b)(4), that servicing practices at getinge (b)(4) are not in compliance to applicable requirements due to identified gaps in quality management system.Specifically, unanticipated repair activities were not submitted as complaints and assessed for reporting as required per regulations and as a result this report was not submitted in a timely manner.Getinge (b)(4) has approved a comprehensive remediation plan and all unanticipated repair activities will be submitted as complaints.Device not returned to manufacturer.

Event Description

On 6th of august 2019 getinge became aware of an issue with the one of our surgical light ¿ hled.As it was stated, the light was not turning all leds and the cover was physically damaged.During inspection it was also revealed that there was lack of grounding.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.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of our light ¿ hled.As it was stated, the light was not turning all leds and the cover was physically damaged.During inspection it was also revealed that there was lack of grounding.There was no injury reported however we decided to report the issue based on the potential as the grounding cable is preventing from electrical discharge, lack of this part is creating risk of electrical shock for operator of the device.It was established that when the issue occurred, the light did not meet its specification as lack of grounding on electrical board could be treated as technical deficiency.The device at hand contributed to the complaint outcome.In the time when the issue occurred the device was not being used for patient treatment.During the investigation it was found that there is no apparent trend with the issue at hand and that the reported malfunction has never lead to serious injury or worse.Despite the effort made in gathering more detailed information it was not provided.The manufacturer¿s subject matter experts have reviewed the case and unfortunately could not provide the specific root cause which wasn¿t possible to be established.We believe that overall the devices in the market related to this issue perform correctly and that if the manufacturer recommendation would have been followed the incident would have been avoided.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).

Manufacturer Narrative

Further to the conclusion which was submitted with 1st follow up report 9710055-2020-00253 (manufacturer's reference number (b)(4)), 2nd 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: 10363725
• MDR Text Key: 201739659
• Report Number: 9710055-2020-00253
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1