BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2527949 · Received April 11, 2012

    Report

    Report Number
    2031642-2012-00161
    Event Type
    Death
    Date Received
    April 11, 2012
    Report Date
    March 23, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIRD PARTY EVALUATION PERFORMED; HOSPITAL CLOSED.

    Description of Event or Problem · 1

    THE RESPIRATORY CARE (RC) DIRECTOR REPORTED THE FOLLOWING: THERE WAS A PATIENT DEATH EVENT THAT OCCURRED IN (B)(6) 2012. HE DOES NOT KNOW THE EXACT DATE AND THE FILE ON THE INCIDENT IS NOT ACCESSIBLE BECAUSE THE HOSPITAL IS CLOSING. THE VENTILATOR WAS IN USE ON A PATIENT AND HAD BEEN PLUGGED INTO AN INCORRECT (NON-VENTILATOR) AC POWER OUTLET. THE POWER CORD HAD BACKED OUT OF THE OUTLET WHICH MAY HAVE BEEN THE RESULT OF THE VENTILATOR BEING MOVED BY NURSING. THE VENTILATOR SWITCHED OVER TO BACKUP BATTERY AND BEGAN ALARMING BUT NO ONE IN THE HOSPITAL RESPONDED TO THE ALARMING AND THE VENTILATOR SHUT DOWN WHEN THE BATTERY DEPLETED UPON USE. RC DECIDED TO HAVE THE VENTILATOR EVALUATED AND TESTED BY AN OUTSIDE BIOMEDICAL ENGINEERING COMPANY WHO REPORTED THEIR TESTING OF THE VENTILATOR FOUND NO PROBLEMS. THE HOSPITAL PERFORMED A ROOT CAUSE ANALYSIS ON THE EVENT AND DETERMINED THERE WAS NO PROBLEM WITH THE VENTILATOR AND THE EVENT WAS DUE TO USER ERROR.

    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 Death