BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULMONETIC

    MDR report key: 1000461 · Received February 21, 2008

    Report

    Report Number
    2031702-2008-00038
    Event Type
    Injury
    Date Received
    February 21, 2008
    Report Date
    February 21, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEM, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    VENTILATOR ALARMS DO NOT SEEM LOUD EVEN WHEN SET TO 80DB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CARDINAL HEALTH 203/PULMONETIC SYSTEM, INC. LTV 900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR