BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40

    MDR report key: 18283250 · Received December 7, 2023

    Report

    Report Number
    2518422-2023-34150
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    February 4, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K121623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RECEIVED AND EVALUATED BY THE MANUFACTURER. IT HAS BEEN CONFIRMED THAT THE VENTILATOR INOPERATIVE ALARM HAD BEEN RECORDED IN THE ERROR LOG. IT WAS CONFIRMED THAT THE OCCURRENCE OF VENTILATOR INOPERATIVE ALARM CAUSED BY E-17 AND THE REBOOT CAUSED BY E-95 HAD BEEN RECORDED IN THE DRPT. MAIN PCA/CIRCUIT BOARD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366191 BIPAP A40 VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. R1111177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown