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

Model Number	SERVO-U
Medical Device Problem Codes	Unintended Collision (1429); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Repair of the device is still ongoing.Further information about faulty parts, device's logs and other circumstances of the issue has been requested but not yet received.Event site name: (b)(6).
Event or Problem Description
It was reported that ventilator generated technical error codes indicating power error after approaching too close to mri scanner.There was no patient harm.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: 25347211
• Report Number: 8010042-2026-0000710
• Device Sequence Number: 15973782
• Product Code: CBK
• UDI-Device Identifier: 07325710010518
• UDI-Public: (01)07325710010518(11)251112
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: SERVO-U
• Device Catalogue Number: 6888800
• 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: 05/21/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown