MAUDE Adverse Event Report: Respironics, Inc. BiPAP A40 Pro, FR; Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

Model Number	FRX3100S14
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging that a ventilator inoperative error code was identified in the event log of a bipap a40 pro device in france during evaluation.This issue has been identified under fsn 2023-cc-src-039 due to interruptions and/or loss of therapy associated with a ventilation inoperative alarm.No patient harm or serious injury was reported in association with this notification.During evaluation of the bipap a40 pro device at a third-party service center, a ventilator inoperative error was confirmed in the event log.The error indicates that the difference between the blower pressure sensor reading and the outlet pressure sensor reading was 10 cmh2o or greater for 5 seconds.The technician identified a faulty printed circuit assembly (pca) as the root cause of the error.No repair was performed.The device will be scrapped at the customer's request.Device logs were not available; therefore, the date of the most recent error codes occurrence could not be determined.At this time, the reported error code event date is based solely on the customer's information received and has not been confirmed through device evaluation.
Additional Manufacturer Narrative
The bipap a40 pro (frx3100s14) is substantially similar to the bipap a40 (1111169) and will be reported in the united states under bipap a40, 501k number: k121623.The reported failure of ventilator inoperative is accommodated in the product risk management file as being linked to hazard with description loss of function/loss of primary function.A field action was initiated with record id fsn 2023-cc-src-039 and r2410297/r2427202, and consisted of a field safety notice.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no further indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.Dhr review was performed for the complaint device sn: (b)(6), review confirms that the device met the final acceptance criteria and was released for final distribution.

• Brand Name: BiPAP A40 Pro, FR
• Common Device Name: Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
• Manufacturer (Section D): Respironics, Inc.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): Respironics, Inc.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; +1(724)733-0200
• MDR Report Key: 50881918
• Report Number: 2518422-2026-046326
• Device Sequence Number: 10667554
• Product Code: MNT
• UDI-Device Identifier: 00606959055100
• UDI-Public: (01)00606959055100
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Device Model Number: FRX3100S14
• Device Catalogue Number: FRX3100S14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown