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

Model Number	CAX3100S12
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bipap a40 pro (cax3100s12) is substantially similar to the bipap a40 (1111169) and will be reported in the united states under bipap a40, 501k number: k121623.
Event or Problem Description
The manufacturer received information alleging a ventilator inoperative alarm was discovered in the bipap a40 pro device's event log.There was no harm or injury reported.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A supplemental report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported information received alleging a ventilator inoperative alarm was discovered in the bipap a40 pro device's event log.There was no harm or injury reported.The device has not yet been returned to the manufacturer for evaluation.Repeated attempts to (b)(6) requesting the device and components returned for evaluation and investigation were unsuccessful.The manufacturer has made sufficient attempts for more information and the return of the device for evaluation, to no avail.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If any additional information is received at a later date, an updated final 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: 22106514
• Report Number: 2518422-2025-106161
• Device Sequence Number: 7022905
• Product Code: MNT
• UDI-Device Identifier: 00606959059405
• UDI-Public: (01)00606959059405
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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
• Device Model Number: CAX3100S12
• Device Catalogue Number: CAX3100S12
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown