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	10/16/2025
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).
Additional Manufacturer Narrative
On-site investigation was performed by our field service engineer.The claimed issue was reproduced during troubleshooting.According to received information, replacement of the o2 gas module solved the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.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 reported issue was not confirmed in provided device's logs as they were not complete.Our conclusion is that the replaced part was the cause of the failure.The defective part was not returned for investigation, despite request.
Event or Problem Description
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: 23434559
• Report Number: 8010042-2025-0001606
• Device Sequence Number: 15586834
• 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
• Report Date (Section B): 10/31/2025

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: 10/23/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/09/2026
• 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