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

Model Number	ARDPWT209029A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
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
On (b)(6), 2023 getinge became aware of an issue with one of surgical lights - powerled ii 500.It was stated due to the air-conditioning water entering the power supply cabinet, one headlight turned off and second turned on.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.
Additional Manufacturer Narrative
The correction of h4 manufacture date deems required.This is based on the internal evaluation.Previous h4 manufacture date: 2020-07-24.Corrected h4 manufacture date: 2020-07-27.Getinge became aware of an issue with one of the surgical lights - powerled ii 500.It was stated due to the air-conditioning water entering the power supply cabinet, one headlight turned off and the second light turned on.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.According to the provided information¿s defective parts have been replaced and device returned to use.It was established that when the event occurred, the surgical light met its specification however leakage of water into the power supply box contributed to the reportable situation.According to the information gathered, the device was not being used for the patient treatment upon the event occurrence.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Comparing the number of affected devices by the investigated issue to the install base, complaint ratio is moderate.A root cause analysis was performed by the subject matter expert at maquet sas.As they stated the presence of water is probably the result of condensation due to the air conditioning or the ambient air of the facility, it is a phenomenon external to the device.This problem is not related to the device, which does not include a water supply.For safety reasons a functional check of the device is required prior to daily use, to verify the absence of damage.Given the findings of this investigation getinge shall continue to monitor for any further events of this nature and does not propose any other action at this time.
Event or Problem Description
Manufacturer's reference number (b)(4).

• Brand Name: 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: 17369197
• Report Number: 9710055-2023-00527
• Device Sequence Number: 20577568
• Product Code: FTD
• UDI-Device Identifier: 03700712407407
• UDI-Public: (01)03700712407407
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: ARDPWT209029A
• Device Catalogue Number: ARDPWT209029A
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown