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

Model Number	ARDPWT609029A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
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 from the headlight handle.We decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
Event site information: (b)(6).Additional information will be provided following the conclusion of the investigation.
Additional Manufacturer Narrative
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 from the headlight handle.We decided to report the issue in abundance of caution as any paint 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.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment or diagnosis.A root cause analysis for investigated problem was performed by subject matter experts and concluded that the paint chip on the handle is probably due to impacts or collisions.To prevent any incident, the powerled ii instruction for use ifu 01811 mentions: - do not use a damaged device because it may lead to a risk of injury for users or a risk of infection for patients.- 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.The correction of h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous e1 initial reporter: (b)(6).Corrected e1 initial reporter: (b)(6).
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: 20638345
• Report Number: 9710055-2024-0000589
• Device Sequence Number: 7488989
• Product Code: FTD
• UDI-Device Identifier: 03700712423094
• UDI-Public: (01)03700712423094
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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
• Device Model Number: ARDPWT609029A
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown