MAUDE Adverse Event Report: MAQUET SAS MAQUET POWERLED II; LAMP, SURGICAL

Model Number	ARDPWT209011A
Medical Device Problem Code	Moisture Damage (1405)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.The received customer allegation regarded flickering light and the issue was considered as a non-reportable.On (b)(6) 2023, the getinge service technician arrived on site and discovered corrosion inside the device on the metal structure and the led segment board with indication of the presence of dried liquid.There was no injury reported, however, we decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
The correction of d1 brand name, d4 version or model #, d4 unique identifier (udi) #, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous d1 brand name: powerled ii.Corrected d1 brand name: maquet powerled ii.Previous d4 version or model # : ard567910957.Corrected d4 version or model # : ardpwt209011a.Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.On 7th july 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.The received customer allegation regarded flickering light and the issue was considered as a non-reportable.On 3rd august 2023, the getinge service technician arrived on site and discovered corrosion inside the device on the metal structure and the led segment board with indication of the presence of dried liquid.There was no injury reported, however, we decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.Based on an information gathered, the device was repaired and returned to clinical use based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification and in this way the device contributed to event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.Root cause analysis was performed by subject matter experts at the manufacturers.As they stated: according to the information provided the presence of water in the surgical light is the result of a water leakage from the facility, it is a phenomenon external to the device.This problem is not related to the device, the pwdii surgical light is not supplied with water and is not a source of a leak.For safety reasons a functional check of the device is required to verify the absence of damage.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: MAQUET POWERLED II
• Common Device Name: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 17507800
• Report Number: 9710055-2023-00581
• Device Sequence Number: 6344296
• Product Code: FTD
• UDI-Device Identifier: 03700712407230
• UDI-Public: (01)03700712407230
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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
• Operator of Device: Health Professional
• Device Model Number: ARDPWT209011A
• Device Catalogue Number: ARD567910957
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown