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

Model Number	ARDPWT229091A
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	03/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
Event or Problem Description
On 19th march 2023 getinge became aware of an issue with one of surgical lights - powerled ii 700.As it was stated, upon the device inspection two out of the six fixation screws holding the device main tube were loose.There was no injury reported, however, we decided to report the issue in abundance of caution as loose screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.
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 700.As it was stated, upon the device inspection two out of the six fixation screws holding the device main tube were loose.There was no injury reported, however, we decided to report the issue in abundance of caution as loose screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.Repair was performed by screws replacement and tightening (ard367270555 - prx/sa - 6 preglued screws chc m6x20) and after that, the device was handed over to the customer and returned to normal use.It was established that when the event occurred, the surgical light did not meet their specifications due to fixation screws holding the device main tube being loosened and, in this way, contributed to the event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing similar reportable events for the same device type, it was confirmed that in the last 5 years, there were no serious 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 issue investigated herein is very low.A root cause analysis was performed by subject matter experts, and it was established that in case of loosening of screws, the probable cause of loosening or breaking corresponds to an improper initial tightening during the installation or a maintenance not in accordance with the manufacturer's recommendations.In case of rupture, the failure of the screws is related to fatigue stresses due to moderate shear overload.All facies have a fatigue failure zone more or less extensive.Initiated at the bottom of the thread, the repeated low mechanical stresses caused the breakage of a first screw.The rupture of the other screws corresponds to progressive propagation of the shear effect.To prevent any incident the yearly preventive maintenance program, mentions to check the tightening of fixation screws on the suspension tube (maintenance manual powerled ii 01810 ver.01, pages 66, 67).In april 2019 getinge transmitted the service bulletin 98a on getinge online reminding to carry out preventive maintenance and wearing parts replacement to ensure the device safety, the service bulletin 98a mentions to replace the suspension fixing screws every 6 years during the preventive maintenance.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.The correction of d4 version of model # deems required.This is based on the internal evaluation.Previous d4 version of model # ard569201957.Corrected d4 version of model # ardpwt229091a.

• 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: 16580643
• Report Number: 9710055-2023-00228
• Device Sequence Number: 4681327
• Product Code: FTD
• UDI-Device Identifier: 03700712411688
• UDI-Public: (01)03700712411688
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 03/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: ARDPWT229091A
• Device Catalogue Number: ARD569201957
• 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: 03/19/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown