BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 864115 · Received September 27, 2006

    Report

    Report Number
    2031702-2006-00223
    Event Type
    Malfunction
    Date Received
    September 27, 2006
    Date of Event
    August 22, 2006
    Report Date
    September 27, 2006
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE CONNECTED TO PT, "FAMILY SAID THE VENT DID NOT HAVE ANY AIR COMING FROM THE CIRCUIT. I TURNED THE MACHINE OFF, THEN DID A LEAK TEST, MACHINE PASSED THE LEAK TEST. WHEN I PLACED THE CIRCUIT BACK ON THE PT, THE LED READ OUT WAS STILL REFLECTING AS IF A VOLUME WAS COMING FROM THE CIRCUIT. THE PT COULD NOT FEEL THE MACHINE VENTILATING AND NEITHER COULD I. WE THEN TOOK THE VENT OFF THE PT." NO ALLEGATIONS OF VENT CAUSING PT HARM. INOP ALARM NOT ACTIVATED, NO OTHER ALARMS DISPLAYED. USED WITH HUMIDIFIER AND CONCENTRATOR AT TIME OF EVENT. WAS ON AC POWER AT TIME. "PT WAS NOT HARMED IN ANY WAY. PT WAS ABLE TO BE DISCONNECTED FROM VENT FOR ABOUT 30 MINUTES WITH NO PROBLEM. WIFE USED AMBU BAG PER SLEEPWELL TO ENSURE HE WAS GETTING OXYGEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK PULMONETIC SYSTEMS, INC. LTV 900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR