MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 PRO, ND; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number	NDX3100S19
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	05/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the discovery of ventilator inoperative error codes during device evaluation.This issue has been identified under fsn 2023-cc-src-039 and may result in interruptions and/or loss of therapy due to a ventilator inoperative alarm.No patient harm or serious injury was reported in association with this event.The device was not in patient use at the time the issue was identified.The returned bipap a40 pro, nd device was evaluated at a third-party service center.Visual inspection found no evidence of foam degradation.Review of the event log confirmed a ventilator inoperative error code indicating that the difference between the blower pressure sensor reading and the outlet pressure sensor reading was 10 cmh2o or greater for 5 seconds.Based on the evaluation findings, the technician recommended replacement of the device's printed circuit assembly (pca) to address the issue.No repair was performed.The device will be scrapped per customer request.
Additional Manufacturer Narrative
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 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 serial number, (b)(6).Review confirms that the device met the final acceptance criteria and was released for final distribution.The bipap a40 pro (ndx3100s19) is substantially similar to the bipap a40 (1111169) and will be reported in the united states under bipap a40, 501k number: k121623.

• Brand Name: BIPAP A40 PRO, ND
• 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 ; 7247330200
• MDR Report Key: 25447959
• Report Number: 2518422-2026-020350
• Device Sequence Number: 12222526
• Product Code: MNT
• UDI-Device Identifier: 00606959059092
• UDI-Public: (01)00606959059092
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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
• Device Model Number: NDX3100S19
• Device Catalogue Number: NDX3100S19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1813-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown