BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEL

    MDR report key: 5082774 · Received September 16, 2015

    Report

    Report Number
    2031702-2015-00213
    Event Type
    Injury
    Date Received
    September 16, 2015
    Date of Event
    August 16, 2015
    Report Date
    September 16, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR PASSED AN EXTENDED TEST RUN USING THE CUSTOMER¿S VENTILATOR SETTINGS. THE VENTILATOR ALSO PASSED THE INITIAL FINAL TEST AND THE ALARM VOLUME TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TRANSPORT OF AN INTUBATED PATIENT, THE PATIENT'S SATS DECLINED. WHEN THE PATIENT'S PEEP AND FIO2 (> 100%) WERE INCREASED, THE PATIENT CONTINUED TO DESAT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED FOR THE REMAINDER OF THE FLIGHT. THE PATIENT'S SATS RETURNED TO ACCEPTABLE LEVELS. NO ALARMS OCCURRED DURING TRANSPORT. THE PATIENT DID HAVE CHEST RISE AND THE VENTILATOR APPEARED TO BE VENTILATING CORRECTLY. THE PATIENT WAS GIVEN ETOMIDATE FOR SEDATION DURING THE INTUBATION AND ALSO HAD 50MCG OF FENTANYL PRIOR TO THE AIR TRANSPORT. WHEN THE PATIENT WAS RECEIVED AT THE HOSPITAL AFTER TRANSPORT, THE RT HAD TO BACK THE ET TUBE OUT AS IT WAS IN THE RIGHT BRANCH. THE VENTILATOR WAS RUN ON THE TEST LUNG AND NO ANOMALIES WERE SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612389 REVEL VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC 19260-001

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R