BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1051266 · Received May 22, 2008

    Report

    Report Number
    2031702-2008-00095
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Report Date
    May 22, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CONNECTED TO THE VENTILATOR, THE APNEA ALARM CAME ON WHEN THE PT WAS BREATHING. THE VENTILATOR ALARMED POWER LOST WHILE USING AC POWER AND WAS LEFT ON THE PT FOR ABOUT 20 MINS. THE UNIT THEN SHUT DOWN AND WAS UNABLE TO BE RESTARTED. THE PT WAS TAKEN OFF THE VENTILATOR. ONE HOUR LATER, THEY TRIED TO TURN THE VENTILATOR BACK ON AND IT WORKED FINE. ACCORDING TO THE NURSE, THIS OCCURRED ONCE PREVIOUSLY. THE PT IS ON THE VENTILATOR ONLY AT NIGHT. NO PT HARM REPORTED.

    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