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

Model Number	CAX3100S12
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bipap a40 pro (cax3100s12) is substantially similar to the bipap a40 and will be reported in the united states under bipap a40, 510k number: k121623.
Event or Problem Description
The manufacturer received information alleging a ventilator inoperative condition occurred.There was no harm or injury reported.The ventilator was returned to the manufacturer's product investigation laboratory (pil) for evaluation and did not observe any issues.Pil tech did take the log from the unit.Pil tech reviewed error logs and noted a ventilator inoperative.This results a device reboot.Pil tech ran the unit at the received settings, on a mechanical quick lung for approximately 30 minutes without error.Ventilator inoperative error not duplicated at pil.Prior to identifying the issue described in fsn 2023-cc-src-039, complaints associated with the issue did not meet requirements for vigilance reporting as a reportable incident.As part of the hhe process, a retrospective review of complaints associated with the issue described in fsn 2023-cc-src-039 was necessary to reassess reportability.Upon this further assessment, these complaints are being reported.

• 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 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 22094285
• Report Number: 2518422-2025-045350
• Device Sequence Number: 20799975
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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: Other
• Device Model Number: CAX3100S12
• Device Catalogue Number: CAX3100S12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2023
• 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