BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS RESPIRONICS E30 WITH HUMIDIFIER

    MDR report key: 23459870 · Received November 3, 2025

    Report

    Report Number
    2518422-2025-111558
    Event Type
    Death
    Date Received
    November 3, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 4, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959060623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING 43 FAMILIES HAVE BEGUN A COLLECTIVE LAWSUIT REGARDING USERS OF PHILIPS RESPIRONICS E30 IN ABC CENTRO MÉDICO, MÉDICA SUR, AND HOSPITAL SAN JAVIER GUADALAJARA IN MEXICO. THE MANUFACTURER RECEIVED INFORMATION ALLEGING 43 DEATHS RELATED TO DEFECTIVE PHILIPS VENTILATORS. THE REPORTED EVENT(S) MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED; THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH, AS WELL AS INFORMATION IN REGARD TO DEVICES. 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
    219674 PHILIPS RESPIRONICS E30 WITH HUMIDIFIER VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. INX9999H19 00606959060623

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death