BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOCAP 5

    MDR report key: 1728349 · Received June 16, 2010

    Report

    Report Number
    9610105-2010-00011
    Event Type
    Death
    Date Received
    June 16, 2010
    Date of Event
    May 19, 2010
    Report Date
    June 16, 2010
    Manufacturer
    GE HEALTHCARE FINLAND
    Product Code
    MLD
    PMA / PMN Number
    K012837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE ANESTHETIST LEFT THE OPERATING ROOM FOR A PERIOD OF TIME. UPON HIS RETURN, HE REPORTEDLY NOTICED THAT THE CARDIOCAP 5 MONITOR DID NOT SHOW SP02 OR NIP DATA. NO ALARM WAS REPORTEDLY HEARD; THE MONITOR SCREEN SHOWED 2 "LITTLE STRIPES". THE ANESTHETIST REPORTEDLY CHECKED THE MONITOR CABLES, WITH NO RESULT. IT WAS SUBSEQUENTLY NOTED THAT THE ANESTHESIA SYSTEM WAS NOT FUNCTIONING IN MECHANICAL MODE. THE ANESTHETIST REPORTEDLY SWITCHED TO MANUAL MODE TO MAINTAIN VENTILATION. THE PATIENT EXPIRED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOCAP 5 CONFIGURED MONITORS MLD GE HEALTHCARE FINLAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Death