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

Model Number	INX3100S19
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A bipap a40 pro device was returned to a third party service center for service.There was no serious patient harm or injury that occurred or was reported.During the evaluation at the third-party service center, the device was visually inspected, and foam particles were observed.The foam insulation needs to be replaced to resolve the issue.No repairs were performed.The device has been scrapped.

• 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: 24222877
• Report Number: 2518422-2026-003659
• Device Sequence Number: 15505453
• Product Code: MNT
• UDI-Device Identifier: 00606959055025
• UDI-Public: (01)00606959055025
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 01/30/2026

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: INX3100S19
• Device Catalogue Number: INX3100S19
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2022
• 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
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1958-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown