BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPAP A40

    MDR report key: 18763544 · Received February 22, 2024

    Report

    Report Number
    2518422-2024-09271
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    September 3, 2015
    Report Date
    February 22, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959042742
    PMA / PMN Number
    K121623
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED AND "THE DEVICE DEFAULTED BACK TO THE FACTORY SETTINGS". THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR HYPERCARBIA WITH THE THOUGHT THAT THEY WERE HYPO-VENTILATING DUE TO DEFAULT SETTINGS". FURTHER INFORMATION CONFIRMED THAT THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS NOT CONFIRMED FOR THE VENTILATION IN-OP AND FOR THE DEVICE DEFAULTING BACK TO THE FACTORY SETTINGS. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WERE THE HEATED HUMIDIFIER (SEE RA# (B)(4)) AND DETACHABLE BATTERY MODULE (SEE RA# (B)(4)) FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237739 BIPAP A40 VENTILATOR,CONTINUOUS,MINIMAL VENTILATOR SUPPORT, FACILITY USE MNT RESPIRONICS, INC. 1109596 00606959042742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other