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

Model Number	1109596
Medical Device Problem Codes	Degraded (1153); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The foam degradation is covered under z-1958-2021.The ventilator inoperative is covered under z-1813-2024.
Event or Problem Description
A bipap a40 device was returned to a third party service center for servicing related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.There was no reported patient involvement.During the evaluation of the device at third-party service center, visible foam particles were found, and the foam insulation was replaced to resolve the issue.Additionally, two ventilator inoperative error codes were found in the device's error log relating to a flow sensor communication as well as a pressure sensor communication error.The main printed circuit assembly (pca) board was replaced to resolve the issues.Additionally, a low circuit leak error code found in the devices error log.It is also noted that extreme dirt and moisture were found during the evaluation.The device software was upgraded, and the device passed all final testing.No further investigation is required.

• Brand Name: BIPAP A40
• 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: 21700143
• Report Number: 2518422-2025-103438
• Device Sequence Number: 18120246
• Product Code: MNT
• UDI-Device Identifier: 00606959042742
• UDI-Public: (01)00606959042742
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial

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: 1109596
• Device Catalogue Number: 1109596
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2024
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2018
• 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-1958-2021; Z-1813-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown