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

Model Number	6688600
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the ventilator was ventilating a patient in the niv nava (non-invasive ventilation neurally adjusted ventilatory assist) mode of ventilation, a leakage was detected.There was no patient harm.Manufacturer's ref.#: (b)(4).
Event or Problem Description
Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
The investigation is based on the received logs and analysis performed by our subject matter expert and tests were performed in the laboratory.Review of the received logs revealed a significant number of check tubing alarm activations can be found on (b)(6) 2025.Check tubing alarm may be triggered in very high leakage situations with at least some patient interfaces with high expiratory resistance due to significant pressure difference between the inspiratory and expiratory pressure transducer.This in turn causes the safety valve and expiratory valve to open for 5 s, resulting in loss of peep (positive end expiratory pressure).The technical log did not contain any technical error codes that could indicate a malfunction of the ventilator.The most common triggering criteria for the check tubing alarm is the exp pressure variation.Breaking up the circuit at the y-piece will with almost 100 % certainty result in check tubing triggered by the exp pressure variation during insp being too small.Our conclusion is that there is no indication of a ventilator malfunction at the time of the event.

• 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: 22932250
• Report Number: 8010042-2025-0001345
• Device Sequence Number: 10231413
• Product Code: CBK
• UDI-Device Identifier: 07325710001042
• UDI-Public: (01)07325710001042(11)191203
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/01/2025

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: 08/14/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown