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

Model Number	ARDPWT609163A
Medical Device Problem Codes	Power Problem (3010); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights ¿ powerled ii.It was determined that the issue from the complaint is not safety and risk related.Then, on (b)(6) 2024, further information was provided by getinge technician following the visit at the customer site and device evaluation.The designated complaint unit employee confirmed based on photographic evidence that the wps power supply cables were loose on an electrical control cabinet, open at the top, without a cover, resulting a risk of electric shock.There was no injury reported, however, we decided to report the issue based on the potential of electrical shock for operator of the device.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.It is unknown if claimed device was or was not being used for patient treatment or diagnosis when the event took place.According to the analysis performed by subject matter expert: observed by technician on-site: wps is not installed and connected correctly.Wps is lying loosely on an electrical control cabinet, open at the top, without a cover, the can connection is not occupied.Curative action: the wps shall be re-installed properly.Root cause defined to be an installation issue.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
Additional Manufacturer Narrative
Event site: (b)(6).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 determined that the issue from the complaint is not safety and risk related.Then, on 22th january 2024, further information was provided by getinge technician following the visit at the customer site and device evaluation.The designated complaint unit employee confirmed based on photographic evidence that the wps power supply cables were loose on an electrical control cabinet, open at the top, without a cover, resulting a risk of electric shock.There was no injury reported, however, we decided to report the issue based on the potential of electrical shock for operator of the device.

• 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: 21408675
• Report Number: 9710055-2025-0000065
• Device Sequence Number: 20891742
• Product Code: FTD
• UDI-Device Identifier: 03700712434281
• UDI-Public: (01)03700712434281
• 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): 02/19/2025

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: ARDPWT609163A
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown