BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-INVASIVE VENTILATOR

    MDR report key: 17611387 · Received August 23, 2023

    Report

    Report Number
    MW5144915
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    August 13, 2023
    Report Date
    August 21, 2023
    Manufacturer
    UNK
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT STATES SHE HAS A NON-INVASIVE VENTILATOR. SHE WAS HOSPITALIZED ON (B)(6) DUE TO THE SETTINGS ON VENTILATOR NOT WORKING AND HER PULSE OX AT 74. SHE STATES SHE DIDN'T TAKE EPCLUSA FROM (B)(6), 2023 DUE TO "NOT BEING ABLE TO HANDLE IT." SHE RESUMED ON (B)(6), 2023. SHE REPORTS "FLU-LIKE SYMPTOMS" AS SIDE EFFECT OF EPCLUSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858783 NON-INVASIVE VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization EPCLUSA