BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVEA VENTILATOR

    MDR report key: 1843544 · Received September 22, 2010

    Report

    Report Number
    MW5017557
    Event Type
    Other
    Date Received
    September 22, 2010
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE AVEA VENTRICULAR SOLD BY CAREFUSION HAS A PROBLEM WITH THE INTERNAL BATTERY. IT SHOULD LAST ABOUT 2 HOURS BUT DUE TO PROBLEMS WITH THE CHARGING CIRCUITS, IT LASTS ONLY 5 MINUTES THEN SHUTS DOWN WITHOUT WARNING. CAREFUSION CAME OUT WITH A NEW GDE (GAS DELIVERY ENGINE) THAT CORRECTS THE PROBLEM. THEY STARTED SHIPPING UNITS WITH THIS IN (B)(6) 2010. OLDER UNITS STILL HAVE THE PROBLEM. WHEN ASKED, CAREFUSION SAYS IT IS THE BATTERY. AFTER PUTTING IN A NEW BATTERY, THE SAME PROBLEM EXISTS. THIS SHOULD BE A RECALL TO CORRECT ALL UNITS AFFECTED. THIS FAILURE CAN CAUSE PATENT HARM OR DEATH SINCE THE VENTILATOR SHUTS DOWN WITH NO WARNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVEA VENTILATOR NONE CBK CAREFUSION

    Patients

    Seq Age Sex Outcome Treatment
    1