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

Model Number	6688600
Medical Device Problem Codes	Improper Flow or Infusion (2954); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator generated clinical alarms indicating insufficient ventilation during treatment.There was no patient harm.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
Initially it was reported that the ventilator generated clinical alarms indicating insufficient ventilation during treatment.During on-site visit, it was confirmed that the ventilation was performed using test lung.The issue was not reproduced, no part was replaced.The device was returned to clinical use.Test lung a specialized accessory designed to simulate a patient¿s lungs during ventilation.The issue will not affect the function of the ventilator as it is used only during ventilation without connecting the device to the patient, therefore this situation is not-safety related, the issue will be displayed and appropriate measures can be taken.A correction of fields # h6 medical device ¿ problem code was required.H6 medical device ¿ problem code: previous: output problem|||3005.Changed: infusion or flow problem|improper flow or infusion||2954.
Event or Problem Description
Manufacturer's reference #: (b)(4).

• Brand Name: BASE UNIT SERVO-N
• 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: 23882796
• Report Number: 8010042-2025-0001906
• Device Sequence Number: 11945167
• Product Code: CBK
• UDI-Device Identifier: 07325710001042
• UDI-Public: (01)07325710001042(11)190918
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 12/23/2025

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: 6688600
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown