MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB BASE UNIT SERVO-U MR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	6888800
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator's wheel was broken.There was no patient harm reported.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
Based on technician statement, the two front wheels no longer work properly.Brake cables were ordered to resolve the issue.The ventilator operates in a field of up to 20mt (200 gauss) for tunnel scanners and up to 10mt (100 gauss) for open scanners.Before using the ventilator in the mr environment, conditions must be met, including locking the two front wheels.The ventilator can be attracted to the mr scanner if the wheels are not locked.The cause of the claimed issue in this customer product complaint has been determined.The issue was related to brake cables.
Event or Problem Description
Manufacturer's ref.#: (b)(4).

• Brand Name: BASE UNIT SERVO-U MR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 20744124
• Report Number: 8010042-2024-0001920
• Device Sequence Number: 8297555
• Product Code: CBK
• UDI-Device Identifier: 07325710010518
• UDI-Public: (01)07325710010518(11)230626
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/21/2024

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: 6888800
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown