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

Model Number	NDX3100S19
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator alarmed and was not functioning.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 report will be submitted when the manufacturer's investigation is complete.The bipap a40 pro is substantially similar to the bipap a40 and will be reported in the united states under, 501k number: k121623.
Additional Manufacturer Narrative
This correction is being sent to report this as a duplicate report.This complaint has been filed under 2518422-2024-100061.All reporting will be done under 2518422-2024-100061.This is a duplicate report.

• 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: 20313260
• Report Number: 2518422-2024-101100
• Device Sequence Number: 18179443
• Product Code: MNT
• UDI-Device Identifier: 00606959059092
• UDI-Public: (01)00606959059092
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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
• Device Model Number: NDX3100S19
• Device Catalogue Number: NDX3100S19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown