MAUDE Adverse Event Report: Maquet Critical Care AB BASE UNIT SERVO-U; Ventilator, Continuous, Facility Use

Model Number	6694800
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
On-site investigation was performed by our field service engineer.The claimed issue was reproduced during troubleshooting.According to the information received in the service report, replacement of the pull magnet resolved the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.The safety valve including pull magnet is located in the inspiratory pipe.The movable axis of the pull magnet closes or opens the safety valve membrane.The pull magnet is controlled by expiratory channel board.The safety valve opening pressure is calibrated to 117 ±3 cmh2o during each pre-use check.The safety valve pull magnet enables the inspiratory gas to be released from the inspiratory pipe via the emergency air intake resulting in decreased inspiratory pressure.The defective part was not returned for investigation despite our request.According to the information received, it was retained by the customer.The reported issue was confirmed in provided device's logs.Our conclusion is that the pull magnet was the cause of the failure.

• Brand Name: BASE UNIT SERVO-U
• 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: 50097558
• Report Number: 8010042-2026-0001037
• Device Sequence Number: 13262411
• Product Code: CBK
• UDI-Device Identifier: 07325710001110
• UDI-Public: (01)07325710001110(11)240214
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2026

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: 6694800
• 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: 07/20/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown