BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEL

    MDR report key: 3892389 · Received June 24, 2014

    Report

    Report Number
    2031702-2014-00162
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 24, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TRANSPORT, THE VENTILATOR WAS NOT OUTPUTTING VOLUME PROPERLY WITH AN AUDIBLE ALARM WHILE CONNECTED TO THE PATIENT. THE PATIENT HAD AN INCREASE IN HIS RESPIRATORY RATE AND HIS O2 SATS HAD DECREASED. THE VENTILATOR WAS REMOVED FROM THE PATIENT AND THE PATIENT WAS MANUALLY VENTILATED FOR THE REMAINDER OF THE TRANSPORT. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367592 REVEL VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC 19260-001

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R