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	01/19/2026
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
Initially it was reported that the o2 gas module was found defective.The o2 gas module regulates the inspiratory gas flow and a faulty o2 gas module may affect the delivered volume or gas mixture (o2/air).The device was inspected by our field service engineer and reported issue was confirmed in the device's logs.However, the issue was not reproduced onsite.No part replacement was required to solve the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.Flow transducer test checks the inspiratory flow transducer, calibrates and checks the expiratory flow transducer, calibrates at 60% o2 and checks at 100% and 21% o2.The cause of the issue has not been determined.
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 ¿ type of investigation code ¿ previous type of investigation code: 10.Corrected type of investigation code: 10, 4121.H6 ¿ investigation findings code ¿ previous investigation findings code: 114.Corrected investigation findings code: 213.H11 ¿ additional manufacturer narrative - previous additional manufacturer narrative: initially it was reported that the o2 gas module was found defective.The o2 gas module regulates the inspiratory gas flow and a faulty o2 gas module may affect the delivered volume or gas mixture (o2/air).The device was inspected by our field service engineer and reported issue was confirmed in the device's logs.However, the issue was not reproduced onsite.No part replacement was required to solve the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.Flow transducer test checks the inspiratory flow transducer, calibrates and checks the expiratory flow transducer, calibrates at 60% o2 and checks at 100% and 21% o2.The cause of the issue has not been determined.Corrected additional manufacturer narrative: an on-site investigation was conducted by our field service engineer, during which the reported issue could not be reproduced.Device logs showed that the ventilator failed flow transducer test due to connected gas supply pressure (air and o2) was not within the specified range to be able to perform the pre-use check.This is a failure that can only occur during pre-use check.With connected good gas sources, multiple pre-use checks were performed with passing results.The ventilator then passed all functional and safety tests and was cleared for clinical use.No parts were necessary to be replaced.There are no indications of ventilator malfunction, the cause was too low gas supply pressure during the pre-use check.This issue is pre-use check related and 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: 24344172
• Report Number: 8010042-2026-0000226
• Device Sequence Number: 9523660
• 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,Followup
• Report Date (Section B): 02/16/2026

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: 01/20/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 05/05/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/20/2026; 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