MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40; 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
Additional Manufacturer Narrative
The bipap a40 pro (inx3100s19) is substantially similar to the bipap a40 (1111169) and will be reported in the united states under bipap a40, 501k number: k121623.
Event or Problem Description
The bipap a40 pro ventilator was returned to the third-party service center in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.There was no allegation of serious or permanent harm or injury.The device was returned to the third-party service center for investigation.During evaluation, evidence of (foam degradation inside the assembly, deteriorated foam) was present.There were no repairs and the device was scrapped.

• 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: 24222102
• Report Number: 2518422-2026-003636
• Device Sequence Number: 9293389
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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
• Device Model Number: INX3100S19
• Device Catalogue Number: INX3100S19
• Was Device Available for Evaluation?: Yes
• 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: 08/22/2022
• 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-1958-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown