BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL STATION

    MDR report key: 865381 · Received June 13, 2007

    Report

    Report Number
    3023750-2007-00153
    Event Type
    Malfunction
    Date Received
    June 13, 2007
    Date of Event
    March 16, 2007
    Report Date
    March 19, 2007
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS A CENTRALIZED PT MONITORING SYSTEM WITH CARDIAC ARRHYTHMIA ANALYSIS SOFTWARE. THE PURPOSE OF THE ARRHYTHMIA ANALYSIS SOFTWARE IS TO ANALYZE PT CARDIAC ECG WAVEFORM MORPHOLOGIES IN REAL TIME AND INDICATE AND ALARM FOR VARIOUS CARDIAC CONDITIONS INCLUDING POTENTIALLY LIFE THREATENING ARRHYTHMIAS SUCH AS ASYSTOLE. THE ACTUAL DEVICE WAS NOT RETURNED BY THE USER FACILITY AS IT IS AN INSTALLED SYSTEM. HOWEVER, THE PT WAVE FORM SNAPSHOT PRINT OUTS FROM THE EVENT WERE FAXED TO WELCH ALLYN AND THE PT WAVEFORM FILES WERE DOWNLOADED FOR ANALYSIS. THE WAVEFORM DATA ARE SUFFICIENT TO CONFIRM THE CUSTOMER'S CLAIM THAT THE SYSTEM DID NOT RECOGNIZE A VENTRICULAR STANDSTILL EPISODE AS ASYSTOLE. THE SYSTEMS DID NOT CALL ASYSTOLE ON THIS PT'S WAVEFORM WHERE THERE WAS NO CARDIAC OUTPUT BECAUSE THE WAVEFORM DID NOT MEET ASYSTOLE CRITERIA. THE WAVEFORM EXHIBITED A DISCERNIBLE ATRIAL BEAT OF SUFFICIENT AMPLITUDE AND DURATION TO SURPASS THE BEAT DETECTION THRESHOLDS SPECIFIED BY ANSI/AAMI EC13 BEAT DETECTION STANDARDS TO WHICH OUR DEVICE COMPLIES. THE DEVICE PERFORMED TO SPECIFICATION. OUR LABELING SPECIFICALLY ADDRESSES THIS TYPE OF PT PATHOLOGY. AS NOTED IN ACUITY DIRECTIONS FOR USE, DOCUMENT 810-1598-03 REV A, CHAPTER 4, PAGE 36, "PATIENT PATHOLOGIES WHERE INDICATIONS OF ELECTRICAL ACTIVITY CONTINUE TO EXIST WITHOUT ADEQUATE CARDIAC FUNCTION MAY NOT BE RECOGNIZED AS ASYSTOLE." DURING THIS EPISODE THE FOLLOWING ALARM CONDITIONS OCCURRED, PAUSE, MISSED BEAT, IRREGULAR, VRHYTHM AND PVC RUN.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED TWO BRIEF EPISODES OF VENTRICULAR TACHYCARDIA AND THE SYSTEM DID NOT ALARM. THE FIRST EPISODE LASTED APPROXIMATELY 11 SECONDS. THE SECOND EPISODE LASTED APPROX 17 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL STATION DSI WELCH ALLYN PROTOCOL, INC. ACUITY SW 6.40.01

    Patients

    Seq Age Sex Outcome Treatment
    1 YR