BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 3063832 · Received March 29, 2013

    Report

    Report Number
    2031702-2013-00059
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE NON-VENTED MASK WAS APPLIED TO THE PT FOR NON-INVASIVE VENTILATION, THE PT STATED THAT THEY WERE "NOT GETTING ENOUGH AIR". THE VENTILATOR WAS ALARMING FOR BLOWER DEMAND EXCEEDED, LOW PRESSURE, AND PT DISCONNECT. THE PT DISCONNECT ALARM WAS REMEDIED BY IMPROVING THE MASK SEAL BUT THE OTHER ALARMS CONTINUED. AFTER ADJUSTING THE MASK AND VENTILATOR, THE PT WAS COMFORTABLE ENOUGH FOR TRANSPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129625 REVEL VENTILATOR, CONTINUOUS /CBK CBK CAREFUSION 203, INC. 19260-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI