BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1013279 · Received March 14, 2008

    Report

    Report Number
    2031702-2008-00048
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    January 29, 2008
    Report Date
    March 14, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT STATED THE BEDSIDE VENT ALLEGEDLY "SHUT OFF" WITHOUT ALARM. THE PT TURNED THE VENTILATOR BACK ON AND HASN'T HAD ANY PROBLEMS SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR