BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40

    MDR report key: 18255516 · Received December 4, 2023

    Report

    Report Number
    2518422-2023-33239
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    August 13, 2017
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K121623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    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 RETURNED TO THE MANUFACTURE FOR EVALUATION AND DURING THE EVALUATION RESULTS THE FOLLOWING REPORTABLE ERROR CODES WERE LOGGED: 68, 101, 103, 104, 163, 177, 201, 203, 204. THE MAIN PCA WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592460 BIPAP A40 VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNT RESPIRONICS, INC. R1111177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown