BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40 PRO

    MDR report key: 18309291 · Received December 12, 2023

    Report

    Report Number
    2518422-2023-34968
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    June 27, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959059139
    PMA / PMN Number
    K121623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIPAP A40 PRO, MODEL# EEX3100S19 IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40, MODEL# 1111169 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40 PRO, 501K NUMBER: 121623. H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213587 BIPAP A40 PRO VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNT RESPIRONICS, INC. EEX3100S19 00606959059139

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown