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	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the information provided by the technician, o2 concentration was set to 60% but during treatment was fluctuation between 22% and 39%.The device was checked on-site, the issue was not reoccurred, no malfunction was found.The device passed all performance tests and could be returned to clinical use.No parts were replaced.No further failures were reported.The device's logs were reviewed and confirm reported issue.The event log confirms several clinical alarms have been generated, as an indication of difficulties with ventilating the patient, but there are no technical error codes to indicate a ventilate malfunction.Alarms such as o2 concentration low, peep low, leakage too high, check tubing, respiratory rate high, expiratory minute volume high or expiratory minute volume low indicates a leakage in the patient circuit.Alarms will be generated when set alarm limits are exceeded, as per design to alert the operator about ongoing issues.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).O2 concentration low alarm may in some cases indicating that the ventilation have been insufficient due to gas delivery error, which represent a reportable event.Unfortunately, as the cause of the leakage was not found, the exact cause could not be determined.
Event or Problem Description
It was reported that the ventilator generated alarms indicating a o2 concentration low, check tubing and leakage too high.There was no patient harm.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: 24827692
• Report Number: 8010042-2026-0000482
• Device Sequence Number: 21121693
• Product Code: MNT
• UDI-Device Identifier: 07325710015117
• UDI-Public: (01)07325710015117(11)250908
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown