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

Model Number	ARDPWT259154A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter was getinge technician.Event site name: (b)(4).Event site telephone: (b)(6).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.It was stated and confirmed by photographic evidence the paint was chipping on main tube.There was no injury, 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.
Additional Manufacturer Narrative
The correction of h4 device manufacture date deems required.This is based on the internal evaluation.Previous h4 device manufacture date 03/11/2021.Corrected h4 device manufacture date 03/25/2021.Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated and confirmed by photographic evidence the paint was chipping on main tube.There was no injury, 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.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.The claimed device was not being used for patient treatment or diagnosis when the event took place.The problem was found during preventive maintenance.A root cause analysis for investigated problem was performed by subject matter experts and concluded that: according to the photographic evidences provided, the ceiling tube involved ard567201355 sn (b)(6) manufactured on 07/2019 has a paint defect at the extremity of the tube.A 8d assessment carried out by our supplier (b)(4) showed that the cause of the poor paint adhesion occurred during the production, more aluminum mass was introduced into the polymerization furnace and at the same chain speed, which meant that the pieces did not reach the correct temperature.Since dec 2022, as corrective actions, a thermograph is used to monitor polymerization conditions.The number of pieces and reference per load in the polymerization oven is limited and the chain speed is reduced to favor the polymerization of the paint, in accordance with the technical data sheet.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: 22059205
• Report Number: 9710055-2025-0000138
• Device Sequence Number: 7812472
• Product Code: FTD
• UDI-Device Identifier: 03700712412845
• UDI-Public: (01)03700712412845
• 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): 05/21/2025

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: ARDPWT259154A
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown