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	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr review was performed for the complaint device serial number (b)(6) review confirms that the device met the final acceptance criteria and was released for final distribution.
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, a ventilator inoperative error code was found in the device's error log stating the difference between the blower pressure sensor reading and the outlet pressure sensor reading is 10 cmh2o or greater for 5 seconds.No repairs were performed.The device will be scrapped per the customer's request.

• 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: 25354676
• Report Number: 2518422-2026-017820
• Device Sequence Number: 13425518
• Product Code: MNT
• UDI-Device Identifier: 00606959055100
• UDI-Public: 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: FRX3100S14
• Device Catalogue Number: FRX3100S14
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2023
• 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