MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 PRO; 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	05/30/2026
Type of Reportable Event	Malfunction
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 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.
Event or Problem Description
The manufacturer received information that a bipap a40 pro device was returned to a third-party service center for service.There was no report of patient harm or injury.The device was not in clinical use.During the evaluation of the device, the device log files were successfully downloaded and reviewed.A ¿ventilator inoperative¿ error was observed, which was attributed to the difference between the blower pressure sensor reading and the outlet pressure sensor reading being 10 cmh2o or greater for 5 seconds.Further assessment determined that the printed circuit assembly (pca) required replacement.A high internal oxygen alarm was also observed, and pca replacement was determined to be necessary to address this condition.Additionally, dust contamination was observed within the device.The device will be scrapped at the customer's request; therefore, no additional repair information was provided.A final report is being submitted.If any additional information is received, a supplemental report will be filed.

• Brand Name: BIPAP A40 PRO
• 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: 25409738
• Report Number: 2518422-2026-019477
• Device Sequence Number: 13337675
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: Other
• Device Model Number: FRX3100S14
• Device Catalogue Number: FRX3100S14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2022
• 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
• Usage of Device: Reuse
• 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