BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1081744 · Received July 18, 2008

    Report

    Report Number
    2031702-2008-00132
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 16, 2008
    Report Date
    July 18, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT WAS PLACED ON THE VENTILATOR FOR TRANSPORT TO RADIOLOGY, THE VENTILATOR SHUT ITSELF OFF. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED FOR TRANSPORT. THE PATIENT WAS PLACED ON A NEW VENTILATOR WHEN THEY ARRIVED TO RADIOLOGY. NO REPORTED HARM TO THE PATIENT. AFTER THE VENTILATOR WAS REMOVED FROM THE PATIENT, IT HAD TURNED ITSELF BACK ON WITH AN AUDIBLE ALARM AND DISPLAYED RESET. THE RESET MODE REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC LTV 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR