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	09/02/2025
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).
Event or Problem Description
Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
The field service engineer (fse) has investigated the reported ventilator on-site.The fse replaced the o2 gas module to resolve the issue and sent back for further investigation.After the replacement, the ventilator passed all functional and safety tests and was cleared for clinical use.The provided logs confirm the reported issue.The returned o2 gas module has been tested in a ventilator.It passed the pre-use check.No issues were found during ventilation for 4 days.It passed another pre-use check after ventilation without any issue.The air and o2 gas modules regulate the inspiratory gas flow and gas mixture.The faulty gas module may lead to stop of ventilation, low o2 or high pressure.The conclusion is that the reported ventilator has failed to meet its specifications during the reported event.Even though, the reported issue could not be reproduced at the manufacturer site, the replaced part still could be the cause of the issue as we know this type of failure is an intermittent failure.

• 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: 23411562
• Report Number: 8010042-2025-0001590
• Device Sequence Number: 10407719
• Product Code: MNT
• UDI-Device Identifier: 07325710015117
• UDI-Public: (01)07325710015117(11)250311
• 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): 10/29/2025

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: 10/02/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown