BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP AUTOSV ADV

    MDR report key: 18431191 · Received January 2, 2024

    Report

    Report Number
    2518422-2024-00153
    Event Type
    Death
    Date Received
    January 2, 2024
    Date of Event
    October 9, 2023
    Report Date
    July 23, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    PMA / PMN Number
    K090539
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING LIVER DISEASE/ TOXICITY, KIDNEY DISEASE/ TOXICITY, LUNG DISEASE. THERE WAS A REPORT OF PATIENT DEATH. THE MANUFACTURER'S INVESTIGATION IS ONGOING. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED. BOX H: EVALUATION METHOD CODE, EVALUATION RESULTS CODE AND CONCLUSION CODE GRID HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING LIVER DISEASE/ TOXICITY, KIDNEY DISEASE/ TOXICITY, LUNG DISEASE. THERE WAS A REPORT OF PATIENT DEATH. 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
    1699525 BIPAP AUTOSV ADV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DS960HS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death