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

Model Number	ARDPWT229090A
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	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device evaluated by mfr: device not returned to manufacturer.
Event or Problem Description
On 16th february, 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.As it was stated the keypad membrane was damaged resulting in missing particle.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
The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 16th february, 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.As it was stated the keypad membrane was damaged resulting in missing particle.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.Corrected b5 describe event and problem: on 15th february, 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.As it was stated the keypad membrane was damaged resulting in missing particle.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 due to damaged keypad membrane, leading to missing particles, which contributed to the event.It is unknown if the device was or was not being used for a patient¿s treatment upon the event occurrence.The review of received customer product complaints related to the investigated issue revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio of the investigated issue is low.A root cause analysis was performed by subject matter experts at the manufacturing site.As they stated, according to the picture provided, the most probable root cause is misuse.It can be observed that the film of the keypad was rubbed which is probably a result of contact with another device.We believe the related devices are performing correctly in the market.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
Event or Problem Description
On 15th february, 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.As it was stated the keypad membrane was damaged resulting in missing particle.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.

• Brand Name: 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: 16416478
• Report Number: 9710055-2023-00121
• Device Sequence Number: 11594890
• Product Code: FTD
• UDI-Device Identifier: 03700712411671
• UDI-Public: (01)03700712411671
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/22/2023

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: ARDPWT229090A
• Device Catalogue Number: ARDPWT229090A
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown