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

Model Number	6688600
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was issue with inaccurate respiratory rate during ventilation.There was no patient harm.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
According to the information provided by our field service engineer (fse), alarm for respiratory rate high was generated.During on-site visit issue was not reproduced by our fse.According to received information, replacement of the patient circuit solved the issue.The device passed all performance tests and was returned to clinical use.Device's logs were not provided for further analysis.Respiratory rate high alarm is a clinical alarm, which indicates difficulties with ventilating the patient.Alarm will be generated when set alarm limits are exceeded, as per design to alert the operator about ongoing issues.Leakage in the breathing circuit may be perceived by the ventilator as breath trigger from the patient and the ventilator will then initiate a support breath and the ventilator starts auto cycling.This will lead to an increase in the respiratory rate.The cause of the issue was determined and it is related to malfunction of the patient circuit.

• 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: 23484944
• Report Number: 8010042-2025-0001633
• Device Sequence Number: 10558684
• Product Code: CBK
• UDI-Device Identifier: 07325710001042
• UDI-Public: (01)07325710001042(11)191028
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/06/2025

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: 10/29/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown