BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DASH 5000

    MDR report key: 1222864 · Received November 6, 2008

    Report

    Report Number
    2124823-2008-00081
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 12, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    DRT
    PMA / PMN Number
    K073462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE REVIEWED THE ECG FULL DISCLOSURE STRIPS WHICH SHOWED THE PRESENCE OF ABUNDANT VENTRICULAR ECTOPY DURING THE COURSE OF MONITORING. THIS ACTIVITY APPEARED TO HAVE BEEN PRESENT BEGINNING AT THE TIME OF ADMISSION AS INDICATED BY THE CLINICIAN'S NOTATION ON ONE OF THE STRIPS PROVIDED. IN THE CASE, THE AVAILABLE DATA SUGGESTS THAT A MAJORITY OF THE BEATS ACQUIRED AND ANALYZED BY THE MONITOR SINCE THE TIME OF ADMISSION MAY HAVE BEEN VENTRICULAR ECTOPIC BEATS. IF SO, IT IS LIKELY THAT THE MORPHOLOGY OF THOSE BEATS WAS LEARNED BY THE ARRHYTHMIA INTERPRETATION ALGORITHM AS BEING "NORMAL" FOR THAT PATIENT. UNDER THAT SCENARIO, THOSE BEATS WOULD NOT BE COUNTED AS PVCS, AND ANY ARRHYTHMIA EPISODES INVOLVING THAT MORPHOLOGY COULD BE INTERPRETED ONLY AS POSSIBLE TACHY EVENTS AND NOT VENTRICULAR ECTOPY EVENTS. GIVEN THE WAVEFORM CONDITIONS PRESENT, DEVICE PERFORMANCE IS WITHIN THE EXPECT LIMITS OF NORMAL OPERATION FOR THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DASH MONITOR ALLEGEDLY DID NOT DETECT A LETHAL ARRHYTHMIA ALARMS. ACCORDING TO THE HCP, THE PATIENT HAD VT- ARRHYTHMIA ALARMS, BUT THE MONITOR GAVE ONLY TACHY ALARMS AND AFIB ALARMS. THE ALGORITHM ALLEGEDLY DID NOT COUNT THE PVC'S. THE MONITOR ONLY PROVIDED A WARNING ALARM OF TACHYCARDIA. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DASH 5000 PATIENT MONITOR DRT GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1