MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-AIR LITE; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number	6893200
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator failed flow transducer test during pre-use check.There was no patient involvement.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
An on-site investigation was conducted by our field service engineer, during which the reported issue was reproduced.According to the service report, the flow transducer test failed during the pre-use check, and replacing the nozzle unit in the o2 gas module resolved the issue.Following this, the ventilator passed all functional and safety tests and was cleared for clinical use.However, the replaced nozzle unit was not returned for investigation, as it was retained by the healthcare facility.The nozzle unit is a component in the gas module, responsible for regulating the inspiratory gas flow to the patient.It comprises a membrane, a mouthpiece, and a feather spring.The membrane is pressed against the mouthpiece by the feather spring to control the gas flow through the gas module.A faulty nozzle unit can lead to ventilation stop, low oxygen levels, or excessive pressure.According to the manufacturer's specifications, the complete nozzle unit should be replaced during preventive maintenance.Based on the information provided, no preventive maintenance has yet been performed, as it is still within one year or 5,000 hours of operation.The reported issue has been confirmed in the device logs.Since the replaced part was not returned for investigation, the exact cause of the failed flow transducer test during the pre-use check has not been definitively determined.However, it is likely that the nozzle unit contributed to the event.
Event or Problem Description
Manufacturer's ref #: (b)(4).

• Brand Name: SERVO-AIR LITE
• Common Device Name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, 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: 24469702
• Report Number: 8010042-2026-0000306
• Device Sequence Number: 10308899
• Product Code: MNT
• UDI-Device Identifier: 07325710015117
• UDI-Public: (01)07325710015117(11)250324
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K230173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: 6893200
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown