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

Model Number	CAX3100T12
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a 'high internal o2"alarm had occurred causing a ventilator inoperative condition to occur on the device.There was no harm or injury reported.The device has not 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.
Additional Manufacturer Narrative
The bipap a40 pro (cax3100t12) is substantially similar to the bipap a40 (1111169) and will be reported in the united states under bipap a40, 501k number: k121623.
Additional Manufacturer Narrative
Correction: the manufacturer received information alleging a 'high internal o2"alarm had occurred causing a ventilator inoperative condition to occur on the device.There was no harm or injury reported.The device has not 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.The udi in section d4 was previously reported in the incorrect format.The udi information has been updated to the correct format.
Additional Manufacturer Narrative
The manufacturer received information alleging a 'high internal o2"alarm had occurred causing a ventilator inoperative condition to occur on the device.There was no harm or injury reported.The philips product investigation lab (pil) is able to confirm the complaint of the a40 pro, visual inspection found no issues.Pil performed testing in accordance with er 2251830 part 001 ver 01 and the results meet the criteria that no further investigation is required.

• 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: 19943275
• Report Number: 2518422-2024-100025
• Device Sequence Number: 4929351
• Product Code: MNT
• UDI-Device Identifier: 00606959059412
• UDI-Public: (01)00606959059412
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2025

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: CAX3100T12
• Device Catalogue Number: CAX3100T12
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 08/22/2024; 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2020
• 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