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

Model Number	6688600
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator generated alarm indicating o2 concentration being too low.There was no patient harm.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
According to the information provided by the technician, the issue with o2 concentration was not reproduced.Device passed all performance and safety tests according to factory specification.The device was delivered to the user in working condition.Nozzle units were replaced as precaution.Evaluation of provided device logs confirmed occurrence of o2 concentration low alarm.Alarm o2 concentration low is activated when measured o2 concentration is below the set value by more than 5 volume % or concentration is below 18 volume % which is independent of settings.There are two main reasons for this alarms: gas delivery error (wrong gas concentration is delivered from the system, but the gas concentration is measured correctly) or measurement error (correct gas concentration is delivered from the system, but the gas concentration is measured incorrectly).As the cause of the alarm activation is unknown, the cause could not be determined.

• 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: 22724876
• Report Number: 8010042-2025-0001225
• Device Sequence Number: 8968129
• Product Code: CBK
• UDI-Device Identifier: 07325710001042
• UDI-Public: (01)07325710001042(11)220425
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 08/06/2025

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: 07/23/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown