BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1033444 · Received April 22, 2008

    Report

    Report Number
    2031702-2008-00072
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    January 13, 2008
    Report Date
    April 21, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR AUTOMATICALLY TURNED ON IN STORAGE. "LN VENT1" EVENTS WERE RECORDED IN THE EVENT TRACE. THE VENTILATOR INOP ALARM WAS ACTIVATED.

    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