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

Model Number	FRX3100S14
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to a ventilator inoperative condition occurring in certain bipap, and mechanical ventilator devices.The manufacturer received information alleging a ventilator inoperative condition on the device.The device has yet to be returned to the manufacturer for evaluation.This issue has been identified under the fsn 2023-cc-src-039.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.The bipap a40 pro (frx3100s14) is substantially similar to the bipap a40 (1111169) and will be reported in the united states under bipap a40, 501k number: k121623.

• 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: 22394753
• Report Number: 2518422-2025-107061
• Device Sequence Number: 9104745
• Product Code: MNT
• UDI-Device Identifier: 00606959055100
• UDI-Public: (01)00606959055100
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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: FRX3100S14
• Device Catalogue Number: FRX3100S14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2022
• 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-1813-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown