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

Model Number	ARDPWT209005A
Medical Device Problem Codes	Corroded (1131); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: medzentrum klinikum bayreuth gmbh.Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - powerled ii.The designated complaint unit employee confirmed based on photographic evidence the paint chipping and rust was visible on suspension arm.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.
Additional Manufacturer Narrative
The correction of d4 version or model # and d4 catalog # fields deems required.This is based on the internal evaluation.Previous d4 version or model #: ard569202911.Corrected d4 version or model #: ardpwt209005a.Previous d4 catalog #: ard569202911.Corrected d4 catalog #: none.Getinge became aware of an issue with one of surgical lights - powerled ii.The designated complaint unit employee confirmed based on photographic evidence the paint chipping and rust was visible on suspension arm.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.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.The claimed device was not being used for patient treatment or diagnosis when the event took place.According to the analysis performed by subject matter expert: this issue of rust on those parts was known with our former supplier and we already had few cases like this.Maquet follows carefully now this issue and among the 332 pieces we had in stock with the new supplier no trace of rust has been detected.The first batch with this new supplier (tmi) was in july 2024 so about this case this part was paint with the former supplier.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
Event or Problem Description
Manufacturer's reference number (b)(4).

• 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: 21642450
• Report Number: 9710055-2025-0000103
• Device Sequence Number: 7574612
• Product Code: FTD
• UDI-Device Identifier: 03700712407179
• UDI-Public: (01)03700712407179
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: ARDPWT209005A
• Device Catalogue Number: ARD569202911
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown