BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARESCAPE B650

    MDR report key: 3569529 · Received January 8, 2014

    Report

    Report Number
    3569529
    Event Type
    Death
    Date Received
    January 8, 2014
    Date of Event
    December 30, 2013
    Report Date
    January 8, 2014
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE REGISTERED NURSE CHECKED ICU PATIENT"S RHYTHM BY PULLING UP THE PATIENT IN THE CENTRAL MONITOR AT THE NURSES' STATION. HE SAW THAT THE SPO2 AND RESPIRATORY RATE LINES WERE FLAT AND HE WAS CONCERNED ABOUT THE RHYTHM HE SAW SO HE WENT TO THE ROOM TO CHECK THE PATIENT. UPON ENTERING THE ROOM, THE NURSE SAW THAT THE PATIENT'S LIPS WERE BLUE AND SHE WAS UNRESPONSIVE DESPITE SHAKING HER TWICE. HE IMMEDIATELY CALLED A CODE BLUE AT 1317. RESUSCITATIVE EFFORTS ENSUED FOR 22 MINUTES AND THE PATIENT REGAINED SINUS RHYTHM AND A BLOOD PRESSURE. THE NURSE WAS CONCERNED THAT THE ALARMS HAD NOT GONE OFF, NOR HAD ANYTHING PRINTED OUT AT THE STATION. HE PRINTED THE FULL DISCLOSURE FROM THE MONITOR AND DISCOVERED THAT THE PATIENT HAD BEEN IN VENTRICULAR TACHYCARDIA AND THEN VENTRICULAR FIBRILLATION SINCE 1306 AT LEAST 9 MINUTES PRIOR TO HIM CHECKING HER RHYTHM AT THE STATION. THE PATIENT WAS MOVED FROM THE ROOM. SHE DETERIORATED AND WENT INTO MULTIPLE ORGAN FAILURE DESPITE MEDICAL EFFORTS. THE PATIENT WAS TRANSFERRED TO HOSPICE CARE AND WAS TAKEN OFF LIFE SUPPORT AT THE REQUEST OF THE FAMILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14321 CARESCAPE B650 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR MHX GE HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death