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

Model Number	IAX3100S19
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to a third-party service center for service.There was no harm or injury reported.During the evaluation of the device at third-party service center, a ventilator inoperative condition occurred.The device's no replacement was done to address the issue.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.
Additional Manufacturer Narrative
On previously submitted report, a ventilator was returned to a third-party service center for service.There was no harm or injury reported.During the evaluation of the device at third-party service center, a ventilator inoperative condition occurred.The device's no replacement was done to address the issue.The device was evaluated by the manufacturer's product investigation laboratory (pil) and the pil could verify that the log taken from the unit, contains 2 err_vent_inop alarms after e-00050 err_pressure_failed errors.Significant indication of ambient contaminants caused obstruction of fine particle inlet filter.Obstruction of filter caused significant restriction to airflow into device.Restricted airflow resulted in insufficient pressure at outlet port.Insufficient pressure at outlet port led to alarms noted in device log.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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 20560265
• Report Number: 2518422-2024-66857
• Device Sequence Number: 16956608
• Product Code: MNT
• UDI-Device Identifier: 00606959059245
• UDI-Public: (01)00606959059245
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: IAX3100S19
• Device Catalogue Number: IAX3100S19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown