BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4180239 · Received September 30, 2014

    Report

    Report Number
    4180239
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 30, 2014
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    STAFF REPORT: PT IN BED 13 IN AFIB, NO ALARM OR MESSAGE ON MONITOR. I DEFAULTED THE MONITOR ALARMS, CHECKED AND DOUBLE CHECKED THE ALARMS WITH NO SUCCESS. I CALLED BIOMED, I DON'T KNOW IF ANYTHING WAS DONE BUT THE "ALARM MESSAGE" WAS BACK LATER THAT DAY.THE NEXT DAY MY PT (BED 13) WENT FROM ST TO AF, I DID NOT NOTICE RIGHT AWAY AS I WAS IN BED 14. THERE WAS NO ALARM FOR PT'S CURRENT AFIB. I CALLED BIOMED, THEY HAVE BEEN TESTING SEVERAL MONITORS ON THE UNIT WITH A SIMULATOR AND NOTED THAT THE BEDSIDE MONITORS WERE NOT PICKING UP AFIB.BED 16 WENT INTO AFIB THIS EVENING, AN ALARM DID GO OFF BUT IT WAS THE ST ALARM BECAUSE THE HEART RATE WAS ABOVE 130 (DEFAULT ALARM IS 90-130). THE PT HEART RATE WAS IN THE 150'S, WAS CURRENTLY STILL IN AFIB WITH NO ADVISORY OR MESSAGE ALARM.MY PT WENT INTO AFIB, HIS HEART RATE WAS BELOW 130 (BELOW DEFAULT). NO AFIB ALARM, HENSE IT WAS NOT NOTICED UNTIL I RETURNED TO HIS ROOM ROOM."CLINICAL ENGINEERING EVALUATION: WE TESTED THE SUSPECT MONITOR AND SEVERAL OTHERS WITH THE SAME SOFTWARE/HARDWARE VERSION. USING TWO DIFFERENT PATIENT SIMULATORS, WE VERIFIED THE MONITOR DID NOT RELIABLY DETECT ATRIAL FIBRILLATION.======================MANUFACTURER RESPONSE FOR CARDIAC MONITOR, GE (PER SITE REPORTER).======================GE TECHNICAL SUPPORT IS INVESTIGATING THE ISSUE. THEY ARE REVIEWING LOG FILES FROM THE EVENTS.======================MANUFACTURER RESPONSE FOR PATIENT DATA MODULE (PDM), GE (PER SITE REPORTER).======================UNDER INVESTIGATION BY GE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607212 * PATIENT MONITOR MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 2016793-003 *
    607295 SOLAR PATIENT MONITOR MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 8000I *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR NO OTHER THERAPIES