BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT

    MDR report key: 519163 · Received March 3, 2004

    Report

    Report Number
    2031642-2004-00044
    Event Type
    Injury
    Date Received
    March 3, 2004
    Date of Event
    January 31, 2004
    Report Date
    March 3, 2004
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    HOSPITAL RISK MGR REPORTED THAT A RESPIRATORY THERAPIST (RT) WALKED BY PT'S ROOM AND NOTICED THAT "PT DIDN'T LOOK GOOD". THE RT REPORTED THE PT'S CONDITION TO THE NURSE, WHO UPON ENTERING THE ROOM, REPORTED THAT THE VENTILATOR WAS ALARMING, BUT THE ALARM VOLUME WAS LOW. THE NURSE REPORTED THE PT WAS FOUND DISCONNECTED FROM THE ESPIRIT AND THE PT'S SPO2 HAD DROPPED TO 22, AND WAS BRADYCARDIC WITH A HEART RATE OF 32. THE PT WAS BAGGED WITH 100% O2 AND THE SPO2 AND HEART RATE RECOVERED TO PRE-DISCONNECT LEVELS. THE RISK MGR REPORTED THE PT HAD SUFFERED NO PERMANENT IMPAIRMENT, AND NEUROLOGICAL STATUS IS NORMAL. THE RISK MGR REPROTED THE PT'S CARDIAC MONITOR HAD BEEN SET TO MESSAGING AND THE PT'S NURSE CALL BUTTON WAS FOUND ON THE FLOOR. IT WAS ALSO REPORTED THAT THE PT WAS LOCATED IN A ROOM SOME DISTANCE AWAY FROM THE NURSES STATION, AND THE ALARM WAS SOUNDING BUT BARELY AUDIBLE OUTSIDE OF ROOM. THE RISK MGR REPORTED THERE WAS NO REMOTE ALARM IN PLACE. THE VENTILATOR WAS TESTED BY RT AND THE ALARM WAS FOUND SET AT ITS MINIMUM SETTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * PULSE OXIMETER, CARDIAC MONITOR.