BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1082398 · Received July 25, 2008

    Report

    Report Number
    2031702-2008-00139
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 25, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BEING TRANSPORTED FROM THE PATIENT'S HOME TO THE HOSPITAL. WHEN THE VENTILATOR WAS HOOKED UP TO THE PATIENT, THE UNIT ALARMED "DISC/SENSE". WHEN THE PARAMEDIC PUT HIS HAND OVER THE TUBE, HE ALLEGEDLY FELT NO AIR. THE PATIENT WAS BAGGED ALL THE WAY TO THE HOSPITAL. NO REPORTED PATIENT HARM.

    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 Hospitalization| R