MAUDE Adverse Event Report: MAQUET SAS POWERLED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	ARDPWD259001A
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	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - powerled.It was stated that fixation screws holding the device main tube were loosen.There was no injury reported, however, we decided to report the issue in abundance of caution as loosen screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Event site name: (b)(6) hospital h3 other text : device not returned to manufacturer.
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.It was stated that fixation screws holding the device main tube were loosen.There was no injury reported, however, we decided to report the issue in abundance of caution as loosen screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.Defective parts were replaced and device returned to usage.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.Device was not being used for patient treatment or diagnosis when the event took place.It was discovered during routine check.Subject matter expert established: in case of loosening, the probable causes of loosening correspond 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.The yearly preventive maintenance program mentions: - to check the suspension fixing screws.It is also indicated to not retighten the screws during maintenance.If screws appear loosened replace them.- to replace the 6 fixing screws every 6 years.In april 2019 getinge transmitted the service bulletin 98 on getinge online reminding to carry out preventive maintenance and wearing parts replacement to ensure the device safety.The service bulletin 98 mentions to replace the suspension fixing screws every 6 years during the inspection.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.The correction of h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.

• Brand Name: POWERLED
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• 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: 17709903
• Report Number: 9710055-2023-00667
• Device Sequence Number: 15132667
• Product Code: FSY
• UDI-Device Identifier: 03700712404383
• UDI-Public: (01)03700712404383
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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: ARDPWD259001A
• Device Catalogue Number: ARDPWD259001A
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown