MAUDE Adverse Event Report: MAQUET SAS POWERLED II 500; LAMP, SURGICAL

Model Number	ARD569202901
Medical Device Problem Codes	Crack (1135); Peeled/Delaminated (1454); 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
E1b event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 24th june, 2024 getinge became aware of an issue with one of surgical lights - powerled ii 500.It was stated the paint was damaged on bracket and sleeve.Photographic evidence confirmed that issue and indicated that paint was damaged with missing particles on fork and arm's sleeve, also keypad membrane on fork was cracked with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - powerled ii 500.It was stated the paint was damaged on bracket and sleeve.Photographic evidence confirmed that issue and indicated that paint was damaged with missing particles on fork and arm's sleeve, also keypad membrane on fork was cracked with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.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.There is no information if the claimed device was not being used for patient treatment or diagnosis when the event took place.Root cause analysis was performed by subject matter expert at manufacturer¿s.The analysis is following: regarding the keypad it can be noticed that the edge of the fork near the keypad is deformed.It means that this part was subjected to a shock probably with another device.This is why the keypad is broken as well.The paint peeling closed to the keypad is also the result of impacts.Regarding the paint damages between the fork and the light head, the most probable root cause is a retention of liquid chemicals in this area.In the product user manual nu_powerledii_01811en12, chapter 6, it is clearly mentioned how to clean the device and a warning about the risk of directly applying water or spray onto the device.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: POWERLED II 500
• 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: 19664333
• Report Number: 9710055-2024-00398
• Device Sequence Number: 6595834
• Product Code: FTD
• UDI-Device Identifier: 03700712407186
• UDI-Public: (01)03700712407186
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/03/2024

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: ARD569202901
• Device Catalogue Number: ARD569202901
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown