BEUDAMED
    FDA Adverse Event Other Summary report: N

    DASH 4000

    MDR report key: 1111703 · Received August 13, 2008

    Report

    Report Number
    2124823-2008-00067
    Event Type
    Other
    Date Received
    August 13, 2008
    Date of Event
    July 17, 2008
    Report Date
    August 13, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K051367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GEHC ENGINEERING REVIEWED THE CIC LOGS FROM ED/12. THE INFO PROVIDED IN THE LOGS SHOWED THAT THE PT WAS NOT INITIALLY ADMITTED TO THE MONITOR. NO PRINTOUTS OF THE ECG WAVEFORMS WERE AVAILABLE FROM THE DASH MONITOR FOR THIS PT ADMISSION. A DISCHARGED DASH MONITOR DISPLAYS THE FOLLOWING RED COLORED TEXT MESSAGE: "ALL ALARMS OFF. ADMIT PT TO ACTIVE ALARMS." IT WAS CONFIRMED THAT THE PT WAS CONNECTED TO THE ECG LEADS SINCE THE SOFTWARE DETECTED LARGE AMOUNTS OF ARTIFACT AROUND 03:11 AM. ADD'L ARTIFACT WAS NOTED AT 04:51 AM. AT 07:08 AM, THE MONITOR WAS ADMITTED, AND A NON-INVASIVE BLOOD PRESSURE (NBP) WAS OBTAINED. AT 07:08 AM, THE NBP SYSTOLIC READING WAS 195MMHG, AND BROADCAST AN AUDIBLE ALARM. THE ALARM SILENCE BUTTON WAS SELECTED MULTIPLE TIMES. AT 07:08:35 AM, THE DASH MONITOR WAS DISCHARGED. FRO 07:37 TO 07:51, THE SOFTWARE DETECTED THE PT EXPERIENCED SEVERAL ARRHYTHMIAS FROM VENTRICULAR TACHYCARDIA, VENTRICULAR FIBRILLATION, AND ASYSTOLE. THE CUSTOMER PROVIDED ECG WAVEFORM PRINTOUTS FROM CODE CART MONITOR THAT HAD A TIME STAMP OF 07:47, SO IT APPEARS THAT THE PT WAS BEING DUEL MONITORED FOR PART OF THIS TIME PERIOD. AT 08:00, THE MONITOR WAS ADMITTED, AND BROADCAST AN SP02 AUDIBLE ALARM. THIS WAS FOLLOWED BY A DISCHARGE, CEASING THE AUDIBLE ALARMS. INVESTIGATION OF THE CIC LOGS INDICATES THAT THE PT WAS NOT ADMITTED TO THE DASH MONITOR AT THE TIME OF THE INCIDENT. THE MONITOR PERFORMED AS DESIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS BEING MONITORED ON THE DASH 4000. THE DASH ALLEGEDLY DID NOT ALARM. THE PT EXPIRED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DASH 4000 PT MONITOR MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death