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

Model Number	6688600
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On-site investigation was performed by our field service engineer.The claimed issue was reproduced during troubleshooting.According to received information in service report, the bacteria filter had a blockage.It was confirmed that non-original expiratory filter was used.Defective filter was replaced and the issue was solved.The alarm along with information about a clogged expiratory bacteria filter indicate an increased expiratory resistance in the patient¿s breathing system.At high expiratory resistance, patient does not have time to breathe properly during the expiratory phase before a new breath is initiated.This leads to the alarms for high pressure is generated.Expiratory airway pressure must be carefully monitored to protect the patient against accidently high airway pressure when using expiratory bacteria filters.Increased airway pressure could result from a clogged expiratory bacteria filter.The filter should be replaced if the expiratory resistance increases or after maximum 24 hours, whichever comes first.The reported issue was confirmed in provided device's logs.The cause of the claimed issue in this customer product complaint has been determined.The issue was related to defective non-original expiratory filter.
Event or Problem Description
It was reported that the ventilator generated an alarm of airway pressure high.There was no patient harm.Manufacturer's ref.#: (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: 23288883
• Report Number: 8010042-2025-0001537
• Device Sequence Number: 5469943
• Product Code: CBK
• UDI-Device Identifier: 07325710001042
• UDI-Public: (01)07325710001042(11)190129
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Report Date (Section B): 10/14/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown