BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40

    MDR report key: 18255392 · Received December 4, 2023

    Report

    Report Number
    2518422-2023-33249
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    August 16, 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 THE REPORTED COMPLAINT COULD NOT BE DUPLICATED IN RUN IN TEST IN SERVICE CENTER. THE FOLLOWING REPORTABLE ERROR CODES WERE LOGGED IN THE ERROR LOG: 68, 101, 103, 104, 177, 201, 203, 204 AND E-65535. THE MAIN PCA WAS REPLACED AS PREVENTATIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429295 BIPAP A40 VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNT RESPIRONICS, INC. R1111177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown