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

Model Number	ARDPWT229063A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 9th september, 2024 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the locking ring from spring arm had come loose and slid out and connector came apart.We decided to report the issue in abundance of caution as loose locking ring could lead to detachment of spring arm and as a result of that, could lead to serious injury.
Additional Manufacturer Narrative
Event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.
Additional Manufacturer Narrative
The initial reporter was hospital technician.Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the locking ring from spring arm had come loose and slid out and connector came apart.We decided to report the issue in abundance of caution as loose locking ring could lead to detachment of spring arm and as a result of that, could lead to serious injury.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.It is unknown if claimed device was or was not being used for patient treatment or diagnosis when the event took place.The mechanical coupling between the spring arm and the main arm has failed because the circlip (or snap ring) was not fully seated in its groove.The root cause is an incorrect fitting during installation or spring arm replacement for maintenance.All the procedure and reminders about the correct fitting of this circlip are detailed in all installation manuals lights where it is involved.This mounting is a critical operation and must be performed according to the rules.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: 20278075
• Report Number: 9710055-2024-0000522
• Device Sequence Number: 12633663
• Product Code: FTD
• UDI-Device Identifier: 03700712411404
• UDI-Public: (01)03700712411404
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 09/23/2024

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: ARDPWT229063A
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown