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

Model Number	6888800
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator became magnetically attracted to a mri scanner.There was no patient harm.Manufacturer's ref #: (b)(4).
Additional Manufacturer Narrative
According to technician statement device was pulled against an mri machine and no part of the ventilator was damaged.The service was handled by customer's biomed.It was confirmed that the ventilator was not secured in a strap from the wall and if the two front wheels were not locked at the time of event.Previous investigations of similar complaints have shown that the ventilator can be attracted to the mr scanner if the wheels are not locked, or if the ventilator is placed inside the safety line.There is a risk of patient injury when the ventilator is attracted to the mr scanner.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 and placing the ventilator outside the 200 gauss (20mt) safety line, which must be marked around the mr scanner.These conditions are stated in the declaration for the use of the ventilator in the mr environment, and are included as part of the "mr environment agreement", which was signed by the facility.Our conclusion is that the incident was most likely caused by the user not following the requirements for use of the ventilator in mr environment.
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: 23788205
• Report Number: 8010042-2025-0001821
• Device Sequence Number: 13381228
• Product Code: CBK
• UDI-Device Identifier: 07325710010518
• UDI-Public: (01)07325710010518(11)241113
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown