MAUDE Adverse Event Report: MAQUET SAS MAQUET EQUIPMENT; HOLDER, CAMERA, SURGICAL

Model Number	ARDSAT239007A
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	12/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: (b)(6).Event site address: (b)(6).Event site telephone: (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 our maquet equipment ¿ eqtmhs013 sat12.As it was stated, one of the fixing screws holding the device main tube was broken.There was no injury reported, however, we decided to report the issue in abundance of caution as broken screw holding the device configuration may lead to the device detachment from the ceiling and serious injury.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our maquet equipment ¿ eqtmhs013 sat12.As it was stated, one of the fixing screws holding the device main tube was broken.There was no injury reported, however, we decided to report the issue in abundance of caution as broken screw holding the device configuration may lead to the device detachment from the ceiling and serious injury.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.The claimed device was not being used for patient treatment or diagnosis when the event took place.According to the information gathered, the issue was discovered during maintenance.A root cause analysis was conducted by the subject matter expert.As stated: 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.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.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
Event or Problem Description
Manufacturer's reference number (b)(4).

• Brand Name: MAQUET EQUIPMENT
• Common Device Name: HOLDER, CAMERA, 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: 21109461
• Report Number: 9710055-2025-0000002
• Device Sequence Number: 18008063
• Product Code: FXR
• UDI-Device Identifier: 03700712411879
• UDI-Public: (01)03700712411879
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 01/08/2025

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: ARDSAT239007A
• 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: 12/26/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown