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

Model Number	CAX3100T12
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned to the manufacturer.
Event or Problem Description
The manufacturer received information alleging a ventilator inoperative condition occurred.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 device was returned to the pil for lab investigation of the device "bipap a40 pro".During the device evaluation, while verifying the patient disconnect alarm, the unit went into ventilator inoperative alarm.Also, the error logs were inspected by pil and found to show ventilator inoperative errors in the log.(6) e-050 pressure regulation alarms preceded the (6) ventilator inoperative alarms in the logs.The etched disk was found to be partially clogged.Results of the investigation did not uncover any details that would impact the risk analysis for the device.However, this is covered in the current product risk analysis merlin risk matrix er# (b)(4) version 29, this failure does not change or modify the risk of the device, currently.It would be covered under tags (b)(4).Pil visually inspected the bipap a40 and did not observe anything to note.Pil tech did take the log from the unit.Pil tech reviewed error logs and noted the ventilator inoperative alarms did show in the error log.E-050 pressure regulation alarms are present in the logs also.When the patient circuit was opened to atmosphere to verify the patient disconnect alarm, the unit alarmed on ventilator inoperative.The unit was disassembled to view the etched disk.The disk is partially clogged with debris that appears to have originated from an external source.In this report, evaluation method code grid, evaluation results code grid, component code grid and conclusion code grid were updated.

• 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: 18370386
• Report Number: 2518422-2023-37015
• Device Sequence Number: 12657402
• Product Code: MNT
• UDI-Device Identifier: 00606959059412
• UDI-Public: 00606959059412
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2020
• 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