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

Model Number	ARDPWT229094A
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 3rd january, 2023 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the support where the device is anchored showed fatigue in the welding to the structure, causing the uneven connection.There was no injury reported, however, we decided to report the issue in abundance of caution as this uneven connection could lead to fall of the device and as a result of that, could lead to serious injury.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
Additional Manufacturer Narrative
The correction of b3 date of event deems required.This is based on the internal evaluation.Previous b3 date of event: 2023-12-30.Corrected b3 date of event: 2022-12-30.The correction of d4 serial # and d4 catalog # deems required.This is based on the internal evaluation.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).Previous d4 catalog # ardpwt229094a.Corrected d4 catalog # ard569201965/ard569202961.Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the support where the device is anchored showed fatigue in the welding to the structure, causing the uneven connection.There was no injury reported, however, we decided to report the issue in abundance of caution as this uneven connection could lead to fall of the device and as a result of that, could lead to serious injury.It was established that when the event occurred, the surgical light did not meet its specification due to fatigue in the welding structure causing the uneven connection of the surgical light, which contributed to the event.According to the information gathered during the investigation, upon the event occurrence the device had not been being used for patient treatment.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 very low.As stated by the subject matter expert at mauqet sas, the anchorage installation has not been performed by getinge technician who confirmed that customer performed it themselves.Information provided by subject matter expert suggests that such a system can collapse.It is strongly recommended to re-install the anchorage according to the rules and recommendations given by the maquet sas.Installation recommendations are included in the installation manual ri 01816 en03.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
Manufacturer's reference number (b)(4).

• 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: 16101344
• Report Number: 9710055-2023-00017
• Device Sequence Number: 17710872
• Product Code: FTD
• UDI-Device Identifier: 03700712408404
• UDI-Public: (01)03700712408404
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 01/05/2023

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: ARDPWT229094A
• Device Catalogue Number: ARD569201965/ARD569202961
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown