BEUDAMED
    FDA Adverse Event Death Summary report: N

    3100A HFOV

    MDR report key: 25116719 · Received May 7, 2026

    Report

    Report Number
    3013421741-2026-00195
    Event Type
    Death
    Date Received
    May 7, 2026
    Date of Event
    April 15, 2026
    Report Date
    April 15, 2026
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SOME INFORMATION WAS NOT PROVIDED AND IS UNKNOWN; THEREFORE, A COMPLETE UDI CANNOT BE PROVIDED. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE EXPERIENCED PRESSURIZATION RELATED ISSUES AND DID NOT ALARM. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307563 3100A HFOV VENTILATOR, HIGH FREQUENCY LSZ VYAIRE MEDICAL, INC 768901 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death