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

Model Number ARD567910968

Device Problems Grounding Malfunction (1271); 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 19th of january 2020 getinge became aware of an issue with the one of our surgical lights.During inspection it was 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.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The purpose of this submission is also to provide a correction of b5: describe event or problem, g4: date received by manufacturer and d1: brand name sections provided in the initial report.This is based on the information provided by the service unit and internal evaluation #b5: previous describe event or problem: on (b)(6) 2020 getinge became aware of an issue with the one of our surgical lights.During inspection it was 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.Corrected additional manufacturer narrative/corrected data: on (b)(6) 2021 getinge became aware of an issue with the one of our surgical lights - hled.During inspection it was revealed that there was lack of grounding.Moreover, photographic evidence was showing paint chipping occurrence.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 and paint particles falling into sterile field are creating risk of contamination.#g4: previous date received by manufacturer: 2020-01-19 corrected date received by manufacturer: 2021-01-19 #d1: previous brand name: surgical light corrected brand name: hled.

Event Description

On (b)(6) 2021 getinge became aware of an issue with the one of our surgical lights - hled.During inspection it was revealed that there was lack of grounding.Moreover, photographic evidence was showing paint chipping occurrence.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 and paint particles falling into sterile field are creating risk of contamination.

Manufacturer Narrative

On 19th january, 2021 getinge became aware of an issue with hled surgical light.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 the 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.The most probable root cause of these paintwork damages is the collision between other products such as the spring arm or light head.Moreover, the paintwork damages are most of the time located on the articulations of arms and spring arms.In all our user manual lights, it is mentioned to check the light heads for chipped paint, impact marks and any other damage.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).The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow to detect the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor pain chip can be repaired with touch up paint, nevertheless the parts impacted by serious damage must be replaced.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: 11222590
• MDR Text Key: 228424858
• Report Number: 9710055-2021-00023
• 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: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD567910968
• Device Catalogue Number: ARD567910968
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/19/2020
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 01/19/2021; 04/30/2021
• Supplement Dates FDA Received: 02/08/2021; 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1