BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40

    MDR report key: 20171506 · Received September 9, 2024

    Report

    Report Number
    2518422-2024-100430
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 26, 2024
    Report Date
    November 6, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959055186
    PMA / PMN Number
    K121623
    Removal / Correction Number
    Z-2037-2025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THE FOLLOWING INFORMATION: THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT MULTIPLE "DEVICE OUT OF SERVICE" ERRORS WERE OBSERVED IN AN A40 PRO DEVICE'S ERROR LOGS. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE BIPAP A40 PRO (DEX3100S13) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, K121623. THE DEVICE WAS EVALUATED BY AN AUTHORIZED SERVICE CENTER. A VENTILATOR INOPERATIVE ERROR WAS FOUND AND CONFIRMED DURING TESTING. THE PRINTED CIRCUIT ASSEMBLY BOARD WILL BE REPLACED TO ADDRESS THE REPORTED ISSUE.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT MULTIPLE "DEVICE OUT OF SERVICE" ERRORS WERE OBSERVED IN AN A40 PRO DEVICE'S ERROR LOGS. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE BIPAP A40 PRO (DEX3100S13) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, K121623.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT MULTIPLE "DEVICE OUT OF SERVICE" ERRORS WERE OBSERVED IN AN A40 PRO DEVICE'S ERROR LOGS. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE BIPAP A40 PRO (DEX3100S13) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, K121623.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020959 BIPAP A40 VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. DEX3100S13 00606959055186

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown