BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHAGENYX

    MDR report key: 21696938 · Received March 26, 2025

    Report

    Report Number
    21696938
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    January 28, 2025
    Report Date
    March 20, 2025
    Manufacturer
    PHAGENESIS LIMITED
    Product Code
    QQG
    UDI-DI
    15060453480004
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT ARRIVED AT THE FLOOR FROM DIALYSIS WITH SKIN VERY COLD, AND PATIENT WAS DIAPHORETIC. PATIENT RESPONDED NAME; PUPIL NON- REACTIVE. ACCESSORY MUSCLE WORK WAS NOTICED. UNABLE TO GET O2 SATURATIONS, TEMPERATURE, BLOOD PRESSURE, PULSE. CPR [CARDIOPULMONARY RESUSCITATION] INITIATED BUT PATIENT DID NOT OBTAIN ROSC [RETURN OF SPONTANEOUS CIRCULATION].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2099858 PHAGENYX OROPHARYNGEAL ELECTRICAL STIMULATOR QQG PHAGENESIS LIMITED PNX-1000 12649771 15060453480004

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male