BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVEL

    MDR report key: 2817459 · Received October 25, 2012

    Report

    Report Number
    2031702-2012-00270
    Event Type
    Death
    Date Received
    October 25, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 25, 2012
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD PASSED AWAY ON (B)(6) 2012. THE PT WAS ON NON-INVASIVE VENTILATION WITH A NON-VENTED MASK. THE PT WAS UNCOMFORTABLE WITH THE NON-INVASIVE VENTILATION, HAD RIPPED THE MASK OFF, AND HAD DESATURATED. THE PHYSICIAN AND PARAMEDIC WERE AT THE PT'S BEDSIDE WHEN THE REPORTED EVENT OCCURRED. THE VENTILATOR HAD A PT CIRCUIT FAULT ALARM CONDITION AT THE TIME OF THE INCIDENT. THE PT'S CONDITION WAS SEVERE AND CONTRIBUTED TO THE DEATH. THERE ARE ALLEGATIONS OF VENTILATOR MALFUNCTION CAUSING PT HARM. NO SPECIFIC MALFUNCTION STATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death