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

Model Number	ARDPWT239221A
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name:(b)(6) event site telephone: (b)(6) additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 25th september, 2024 getinge became aware of an issue with one of surgical light - maquet powerled ii.It was stated that there was a power failure and the battery supply did not work.Therefore the lights went out during the operation and the surgeon was in the dark.Only when the emergency power generator was started up for the operation did they light up again.We decided to report the issue in abundance of caution as the extinction of surgical light system during procedure may cause serious injury in case of reoccurrence.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical light - maquet powerled ii.It was stated that there was a power failure and the battery supply did not work.Therefore the lights went out during the operation and the surgeon was in the dark.Only when the emergency power generator was started up for the operation did they light up again.We decided to report the issue in abundance of caution as the extinction of surgical light system during procedure may cause serious injury in case of reoccurrence.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.According to the information received by getinge, the issue occurred during surgery.According to the technician it was not possible to reproduce the fault.Root cause analysis was performed by subject matter experts at the manufacturer.As they stated, it is not possible to determine the root cause of this failure.Maquet did not receive enough information to conduct the technical investigation.It is not possible to determine the root cause nor provide the most probable root causes.In case of new relevant information, the case will be reconsidered.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.The initial reporter was operating room staff.The correction of d4 catalog #, d4 serial # and h6 component codes fields deems required.This is based on the internal evaluation.Previous d4 catalog #: ard569242911 corrected d4 catalog #: n/a previous d4 serial #: (b)(6), corrected d4 serial #: (b)(6).Previous h6 component codes: mechanical|dome||793 corrected h6 component codes: electrical and magnetic|battery||420.
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: 20380732
• Report Number: 9710055-2024-0000543
• Device Sequence Number: 20834052
• Product Code: FTD
• UDI-Device Identifier: 03700712412593
• UDI-Public: (01)03700712412593
• 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): 10/03/2024

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
• Operator of Device: Health Professional
• Device Model Number: ARDPWT239221A
• Device Catalogue Number: ARD569242911
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown