BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 2830451 · Received October 10, 2012

    Report

    Report Number
    2031702-2012-00252
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Report Date
    October 9, 2012
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PARAMEDICS REMOVED THE PATIENT FROM THE HOSPITAL VENTILATOR AND PLACED THE PATIENT ON ANOTHER VENTILATOR FOR TRANSPORT. THE TRANSPORT VENTILATOR WOULD CYCLE FIVE TIMES AND THEN STOP WITH A BLOWER DEMAND ALARM AND A PATIENT CIRCUIT FAULT ALARM. THE PATIENT WAS USING THE VENTILATOR NON-INVASIVELY WITH A MASK. THE PATIENT WAS PLACED BACK ON THE HOSPITAL VENTILATOR. NO PATIENT HARM REPORTED.

    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