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	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of provided information and device's logs: on-site investigation was performed by our field service engineer.The claimed issue was reproduced during troubleshooting.During on-site visit it was observed that, along low o2 concentration, alarms indicating leakage occurred, which was is explained by the user as a result of patient trying to take the mask off.Evaluation of device's logs confirmed occurrence of mentioned alarms.Further investigation of the issue is required.
Event or Problem Description
It was reported that ventilator generated an alarm of low o2 concentration.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: 25174931
• Report Number: 8010042-2026-0000636
• Device Sequence Number: 21367007
• Product Code: MNT
• UDI-Device Identifier: 07325710015117
• UDI-Public: (01)07325710015117(11)250815
• Combination Product (Y/N): N
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: 04/22/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown