BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1172054 · Received September 17, 2008

    Report

    Report Number
    2031702-2008-00176
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Report Date
    September 16, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR RESET WITH AN AUDIBLE ALARM. WHEN THE PARENTS OF THE PATIENT TURNED THE VENTILATOR OFF THE VENTILATOR WOULD TURN ITSELF BACK ON AGAIN. THE PATIENT WAS NOT ON THE VENTILATOR AT THE TIME OF THE RESET CONDITION, THEREFORE, THERE WAS NO HARM TO THE PATIENT.

    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