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	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the inspection of the ventilator it was discovered that internal leakage test failed during pre-use check.There was no patient involvement.Manufacturer's ref.#: (b)(4).
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 replacement of the pressure transducer printed circuit board (pcb) and expiratory channel printed circuit board (pcb) solved the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.Pressure transducer pcb measures the pressure, conveyed via the pressure tube connected to this block by its differential pressure transducer.With differential reference to the ambient pressure, the output signal is proportional to the measured pressure thus giving a linear measurement in the range -40 cmh2o to +160 cmh2o.The expiratory channel pcb contains electronics including microprocessor for handling of expiratory flow measurement performed by the flowmeter inside the cassette, all electronic connections to and from the cassette, expiratory valve control, safety valve control, temperature monitoring and also holders and electrical connectors for the expiratory and inspiratory pressure transducer boards.The device's logs and the claimed part were not provided for further analysis.The cause of the claimed issue in this customer product complaint has been determined.The issue was related to pressure transducer pcb and expiratory channel pcb.
Event or Problem Description
Manufacturer's ref.#: (b)(4).
Event or Problem Description
Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
Corrections were required in the following fields: h6 ¿ investigation findings code ¿ previous investigation findings code: 114.Corrected investigation findings code: 115.H6 ¿ component code ¿ previous component code: missing.Corrected component code: 484 h6 ¿ investigation conclusions code ¿ previous investigation conclusions code: 4307.Corrected investigation conclusions code: 51.H11 ¿ additional manufacturer narrative - previous 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 replacement of the pressure transducer printed circuit board (pcb) and expiratory channel printed circuit board (pcb) solved the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.Pressure transducer pcb measures the pressure, conveyed via the pressure tube connected to this block by its differential pressure transducer.With differential reference to the ambient pressure, the output signal is proportional to the measured pressure thus giving a linear measurement in the range -40 cmh2o to +160 cmh2o.The expiratory channel pcb contains electronics including microprocessor for handling of expiratory flow measurement performed by the flowmeter inside the cassette, all electronic connections to and from the cassette, expiratory valve control, safety valve control, temperature monitoring and also holders and electrical connectors for the expiratory and inspiratory pressure transducer boards.The device's logs and the claimed part were not provided for further analysis.Corrected additional manufacturer narrative: biomed technician at the healthcare facility contacted the getinge field service engineer after replacing the pc 2024 expiratory channel pc board and the pc1781 pressure transducer pc board due to a failure in the internal leakage test during the pre-use check.Despite these replacements, the issue persisted.Getinge field service engineer disassembled the inspiratory pipe and cleaned the safety valve membrane.The ventilator then passed pre-use check and was cleared for clinical use.The root cause of the initial failure in the internal leakage test was identified as debris on the safety valve membrane.This issue is detectable during pre-use check and cannot occur during ventilation.It can be addressed before initiating ventilation.Therefore, it is deemed non-reportable.The situation does not indicate a potential to cause or contribute to death or serious injury, thus meeting the criteria for non-reportability.

• 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: 24468672
• Report Number: 8010042-2026-0000302
• Device Sequence Number: 10277946
• Product Code: MNT
• UDI-Device Identifier: 07325710015117
• UDI-Public: (01)07325710015117(11)240516
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,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: 04/03/2026; 05/05/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/03/2026; 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown