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	06/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator inoperative condition occurred.There was no harm or injury reported.The device has been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.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
The manufacturer previously reported receiving information alleging a ventilator inoperative condition occurred.There was no harm or injury reported.The pil tech can confirm the e-046 err_flow_sensor_communication_error in the error log and the oxygen exhaust fan runs with power application to the unit.The alarm was not duplicated at the pil.The device is suspected to have a faulty 02 sensor on the main pca.This is being investigated under capa 1773526.The o2 sensor reads 24.2 at ambient conditions.There is evidence that the customer received a replacement, this unit has been scrapped per the requirements set forth in work instruction 8.4-1131 rev 9 and disposed of accordingly.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: 21147787
• Report Number: 2518422-2025-002352
• Device Sequence Number: 18553235
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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?: Yes
• Date Returned to Manufacturer: 06/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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
• 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