BEUDAMED
    FDA Adverse Event Death Summary report: N

    G.E. SOLAR 8000I

    MDR report key: 1352683 · Received March 24, 2009

    Report

    Report Number
    1352683
    Event Type
    Death
    Date Received
    March 24, 2009
    Date of Event
    January 23, 2009
    Report Date
    March 24, 2009
    Manufacturer
    G.E. WISCONSIN
    Product Code
    MHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT - POST BYPASS SURGERY WAS PLACED ON A G.E. MONITOR IN THE CV-ICU. IN 2009, THE PT GOT OUT OF BED WITHOUT ASSISTANCE TO USE THE BEDSIDE TOILET. WHILE ON THE TOILET, HE HAD A BRADY EVENT. THE PT WAS FOUND WITHIN MINUTES ON THE FLOOR UNRESPONSIVE. THE CODE WAS INITIATED. THE PT EXPIRED THE FOLLOWING DAY. THE PT REMAINED ON THE MONITOR DEVICE THROUGHOUT THE EVENT AND THE CODE. WE DO NOT KNOW IF THE ALARMS SOUNDED. DURING OUR ROOT CAUSE ANALYSIS, WE DISCOVERED POSSIBLE INCONSISTENCIES IN THE MONITOR STRIPS AND THE ALARM CODES. THE STRIPS SHOW A BRADY EVENT, BUT WE ARE NOT YET CERTAIN IF THE ALARMS SOUNDED PROPERLY. WE ARE STILL INVESTIGATING THIS EVENT. WE CONTACTED THE MANUFACTURER AND THEY ARE HELPING US TO DEVELOP CLARITY. GE COMPLAINT. JUST BECAME AWARE ABOUT TWO MONTHS LATER, THAT THERE MAY BE A DEVICE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G.E. SOLAR 8000I PATIENT MONITOR MHX G.E. WISCONSIN 8000I

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death