BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40

    MDR report key: 24782055 · Received April 3, 2026

    Report

    Report Number
    2518422-2026-010457
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 3, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959067677
    PMA / PMN Number
    K121623
    Removal / Correction Number
    Z-1813-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED FAILURE OF VENTILATOR INOPERATIVE IS ACCOMMODATED IN THE PRODUCT RISK MANAGEMENT FILE AS BEING LINKED TO HAZARD WITH DESCRIPTION LOSS OF FUNCTION/LOSS OF PRIMARY FUNCTION. A FIELD ACTION WAS INITIATED WITH RECORD ID Z-1813-2024 AND CONSISTED OF A FIELD SAFETY NOTICE. COMPLAINTS FOR THIS FAILURE ARE REVIEWED VIA THE POST MARKET COMPLAINT TRENDING AND ESCALATION PROCESSES TO ASSESS FOR THE OBSERVED PROBABILITY LEVELS AND COMPARE THEM WITH THE PREDICTED LEVELS IN THE RISK FILE FOR THE HAZARDS LINKED TO THE FAILURE. AS OF THE DATE OF SUBMISSION FOR THIS REPORT, THERE IS NO FURTHER INDICATION THAT COMPLAINTS FOR THE FAILURE IN QUESTION HAS LED TO UNACCEPTABLE INCREASE IN PROBABILITY LEVELS FOR THE HAZARDOUS SITUATIONS IN SCOPE, AND THEREFORE NO FURTHER ACTION WILL BE PURSUED. QA CONTINUES TO MONITOR COMPLAINTS FOR THIS ISSUE PER THE CADENCE IN THE COMPLAINT TRENDING PROCEDURES.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A VENTILATOR INOPERATIVE CONDITION WAS REPORTED ON A BIPAP A40 DEVICE. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN 2023-CC-SRC-039 DUE TO INTERRUPTIONS AND/OR LOSS OF THERAPY DUE TO A VENTILATION INOPERATIVE ALARM. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR REPAIR. DURING EVALUATION OF THE DEVICE, THE SERVICE CENTER VERIFIED A VENTILATOR INOPERATIVE CONDITION. THE TECHNICIAN REPLACED THE DEVICE'S MAIN PCA TO ADDRESS THE ISSUE. THE DEVICE PASSED FINAL TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150640 BIPAP A40 VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. 1111169 00606959067677

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown