BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40 PRO

    MDR report key: 20188457 · Received September 11, 2024

    Report

    Report Number
    2518422-2024-57921
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    May 8, 2024
    Report Date
    September 12, 2024
    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# CAX3100S12 IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 1111177 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40 PRO, 501K NUMBER: K121623.

    Additional Manufacturer Narrative · 0

    PREVIOUSLY REPORTED BY THE MANUFACTURER: THE BIPAP A40 PRO MODEL# CAX3100S12 IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 1111177 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40 PRO, 501K NUMBER: K121623. NEW INFORMATION: THE MODEL NUMBER WAS INCORRECTLY REPORTED IN BOX H ADDITIONAL NARRATIVE. CORRECT INFO: THE BIPAP A40 PRO MODEL# EEX3100S19 IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 1111177 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40 PRO, 501K NUMBER: K121623.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. 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
    1588804 BIPAP A40 PRO VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNT RESPIRONICS, INC. EEX3100S19 00606959059139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown