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

Model Number	ARDPWT259215A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The device reference number for the medical device referred to in this medical device report cannot be verified, and therefore, no udi number can be provided.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 the paint was chipping from device.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
The issue was reported by an infection prevention member employed by the account.The correction of d1 brand name, d4 catalog #, d4 unique identifier (udi) #, h3a device evaluated by mfg and 3b device not eval provide code deems required.This is based on the internal evaluation.Previous d1 brand name: powerled ii corrected d1 brand name: maquet powerled ii.Previous d4 catalog # ardpwt259215a corrected d4 catalog # none.Previous d4 unique identifier (udi) #: n/a corrected d4 unique identifier (udi) #: (b)(4).Previous h3a device evaluated by mfg: no corrected h3a device evaluated by mfg: yes previous h3b device not eval provide code: device evaluation anticipated, but not yet begun corrected h3b device not eval provide code: none.Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the paint was chipping from device.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.The claimed device was not in use for patient treatment or diagnosis when the event took place.The issue was discovered during an infection control rounding.Root cause analysis was performed.As stated by the subject matter expert, it was confirmed that the cleaning has not been performed according to our ifu.Similar issues have been raised in the past.Over saturated rags are being used.The light is not dried of excess cleaner.A hydrogen peroxide based cleaner is being used.All of this has been brought up that it is harmful to the lights and the customer had been provided our suggested cleaning ifu.Indeed, hydrogen peroxide is an aggressive chemical agent for paint and this is here the root cause of this paint chipping.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: 20521901
• Report Number: 9710055-2024-0000578
• Device Sequence Number: 7920318
• Product Code: FTD
• UDI-Device Identifier: 03700712413897
• UDI-Public: (01)03700712413897
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: ARDPWT259215A
• Device Catalogue Number: ARDPWT259215A
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown