BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1063456 · Received June 20, 2008

    Report

    Report Number
    2031642-2008-00148
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 27, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    CLINICAL COORDINATOR REPORTED THE FOLLOWING: RESPIRATORY THERAPIST (RT) REPORTED PT WAS DOING FINE AT SHIFT CHANGE. PT WAS INTUBATED AND ON THE VENTILATOR FOR 1.5-2 HOURS WITHOUT PROBLEMS. THE RT HEARD THE VENTILATOR ALARMING AND UPON ENTERING THE ROOM REPORTED THE PT APPEARED TO BE STACKING BREATHS. WHILE THE RT WAS TRYING TO DETERMINE THE REASON THE VENTILATOR WAS ALARMING, THE PT CODED. THE PT WAS SUCCESSFULLY RESUSCITATED AND PLACED BACK ON THE VENTILATOR WHEN IT WAS NOTED THE PT WAS STUCK AGAIN STACKING BREATHS. THE PT WAS REMOVED FROM THE VENTILATOR AND BAGGED, AND AGAIN PLACED BACK ON THE VENT WITH THE SAME RESULT. THE PT WAS TAKEN OFF THE VENTILATOR AND PLACED ON ANOTHER VENTILATOR. THE PT SUFFERED NO PERMANENT HARM. AFTER THE EVENT, THERE WAS A DISCUSSION WITH ANOTHER RT ABOUT THE PT FINDINGS DURING THE EVENT, AND THE RT REPORTED THE PT WAS NOTED TO HAVE DONE THE SAME THING (STACKING BREATHS) DURING A PREVIOUS HOSPITALIZATION. THE MFR'S SERVICE TECHNICIAN PERFORMED EXTENDED SELF TESTING (EST) AND ALL TESTS PASSED TO OPERATING SPECIFICATIONS. NO PROBLEMS OR FAILURES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention