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

Model Number	ARDPWT259054A
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 22nd june 2024 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the dual fork assembly of the lighthead has been damaged.It was confirmed by video evidence the connection between fork and spring arm was damaged with risk of detachment.The issue was detected during pre-use check of the light.There was no injury reported, however, we decided to report the issue in abundance of caution as break on the connection between fork and spring arm could lead to fall of the device and as a result of that, could lead to serious injury.
Additional Manufacturer Narrative
Event site state: (b)(6) contact person phone number: (b)(6).Additional information will be provided following the conclusion of the investigation.
Additional Manufacturer Narrative
The correction of d1 brand name, d4 model #, d4 catalog # and d4 unique identifier (udi) #, h3a device evaluated by manufacturer, h3b device not eval provide code and h4 device manufacture date fields deems required.This is based on the internal evaluation.Previous d1 brand name powerled ii corrected d1 brand name maquet powerled ii.Previous d4 model # ard569201917.Corrected d4 model # ardpwt259054a.Previous d4 catalog # ard569201917.Corrected d4 catalog # n/a.Previous d4 unique identifier (udi) # n/a.Corrected d4 unique identifier (udi) # (b)(4).Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: device evaluation anticipated, but not yet begun.Corrected h3b device not eval provide code: n/a.Previous h4 device manufacture date 01/17/2019.Corrected h4 device manufacture date 06/27/2019.Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the dual fork assembly of the lighthead has been damaged.It was confirmed by video evidence the connection between fork and spring arm was damaged with risk of detachment.The issue was detected during pre-use check of the light.There was no injury reported, however, we decided to report the issue in abundance of caution as break on the connection between fork and spring arm could lead to fall of the device 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.The claimed device 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: the fork ard569201002 involved was sent back to the factory and was then assessed by an external laboratory "filab".The conclusion of the filab report (b)(4) indicates that multiple pores were observed in various analyses, suggesting that the primary cause is a welding failure.Measures undertaken by (b)(4) (supplier): the fork involved was produced in june 2019.It should be noted that the aluminum welding line has been considerably modernized to increase the quality of the parts.Since june 2022, as corrective action (b)(4) improved weld setting to ensure weld penetration and thickness and use radius gauge r6 to check the weld joint after grinding.Measures undertaken by getinge: the test report re 18-073, on welding connection of the forks, requested by the verification plan of the powerled ii project, indicates that the load test comply with the requirements of iec 60601-1 ed.3.1.To prevent any incident the powerled ii instructions for use (01811) mentions to check that the device has not suffered any impact damage and to check for any chipped or missing paint during the daily inspections before use.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: 19612919
• Report Number: 9710055-2024-00386
• Device Sequence Number: 6197769
• Product Code: FTD
• UDI-Device Identifier: 03700712408749
• UDI-Public: (01)03700712408749
• Combination Product (Y/N): N
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: ARDPWT259054A
• Device Catalogue Number: ARD569201917
• 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: 06/22/2024
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown