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

Model Number	ARDPWT609059A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: (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 our surgical lights - maquet powerled ii.As it was stated, there was a collision with the light and the cover for the front knuckle of the spring arm fell off.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.
Additional Manufacturer Narrative
The correction of h4 manufacture date deems required.This is based on the internal evaluation.Previous h4 manufacture date: 2024-05-01.Corrected h4 manufacture date: 2024-04-29.Getinge became aware of an issue with one of our surgical lights - maquet powerled ii.As it was stated, there was a collision with the light and the cover for the front knuckle of the spring arm fell off.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.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.It is not known if claimed device was or was not being used for patient treatment or diagnosis when the event took place.A root cause analysis for investigated problem was performed by subject matter experts and concluded that: according to the last information provided, the cover was removed by the customer after being damaged by a collision.The initial cause is a misuse.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: 21432693
• Report Number: 9710055-2025-0000071
• Device Sequence Number: 4606150
• Product Code: FTD
• UDI-Device Identifier: 03700712423360
• UDI-Public: (01)03700712423360
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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
• Device Model Number: ARDPWT609059A
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown