BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 852680 · Received May 18, 2007

    Report

    Report Number
    3023750-2007-00136
    Event Type
    Other
    Date Received
    May 18, 2007
    Date of Event
    September 27, 2006
    Report Date
    October 23, 2006
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K022453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S EVAL SUMMARY: THE DEVICE IS AN INSTALLED CENTRALIZED PT MONITORING SYS THAT UTILIZES A SUNBLADE 150 CENTRAL PROCESSING UNIT (CPU). THE DEVICE RECEIVES, ANALYZES AND DISPLAYS PT VITAL SIGNS DATA FROM MULTIPLE BEDSIDE MULTIFUNCTIONAL PT MONITORING DEVICES THROUGH EITHER WIRED OR WIRELESS CONNECTIONS. THIS CUSTOMER REPORTED TWO SEPARATE ISSUES. THE FIRST ISSUE WAS THAT THE ACUITY SYS LOST CONTACT WITH BESIDE PT MONITORS FOR AN INDETERMINATE TIME. THE SECOND ISSUE REPORTED WAS THAT ACUITY MADE ERRONEOUS ARRHYTHMIA ANALYSIS ALARM INDICATIONS. THE USER FACILITY SUBSEQUENTLY REPORTED THESE ISSUES TO FRENCH REGULATORY AUTHORITIES. IN THIS REPORT TO THE AUTHORITIES, THE RPTR DID NOT INDICATE ANY CLINICAL CONSEQUENCES RESULTING FROM THE REPORTED ISSUES. WE HAVE INCLUDED A COPY OF THAT REGULATORY FILING IN THIS MDR FOR REFERENCE. WE DOWNLOADED THE SYS LOGS AND EXAMINED THEM. WE COULD NOT FIND ANY EVIDENCE OF A LOSS OF CONTACT WITH THE BEDSIDE MONITORS. WE INFORMED OUR FRENCH SUPPORT PERSONNEL THAT IF THE USER SHUTS DOWN THE BEDSIDE MONITOR WHILE ISSUING CERTAIN COMMANDS, THEN IT MAY APPEAR TO SOMEONE SITTING AT THE CENTRAL ACUITY STATION THAT THE SYSTEM LOST CONTACT WITH THE BEDSIDE MONITOR. WE ALSO INVESTIGATED WIRELESS COVERAGE IN THE CLIENT HOSP AND FOUND THAT THERE APPEARED TO BE MORE WIRELESS CAPACITY THAN NEEDED. WE GAVE OUR INTERNATIONAL AFFILIATE EMPLOYEES GUIDANCE ON HOW TO DETERMINE WHETHER THEY HAVE PROVIDED ADEQUATE WIRELESS CAPACITY. EXCESS WIRELESS CAPACITY SHOULD NOT CAUSE EXTENDED DROPOUT. THE ERRONEOUS ARRHYTHMIA ANALYSIS INDICATIONS NOTED BY THE CUSTOMER WERE BOTH FALSE ALARMS FOR A LIFE THREATENING ARRHYTHMIAS (LTA). WE REC'D SCANNED WAVEFORM SNAPSHOTS FOR TWO PTS. PID 22222 EXHIBITED ATRIAL FLUTTER, WHICH THE ARRHYTHMIA ANALYSIS SOFTWARE FALSELY ALARMED AS VENTRICULAR FIBRILLATION (VFIB). THE ARRHYTHMIA ANALYSIS SOFTWARE SOMETIMES HAS DIFFICULTY DISTINGUISHING BETWEEN ATRIAL FLUTTER, WHICH IS A NON-LIFE THREATENING ARRHYTHMIA (LTA), AND VFIB, WHICH IS AN LTA. THIS IS A LIMITATION OF THE EXISTING TECHNOLOGY AND NOT A DEVICE MALFUNCTION. THE SECOND SCANNED WAVEFORM SNAPSHOT, PID 22, EXHIBITED A PACED PT WHERE THE PT WAVEFORM WAS CLEARLY NOT ASYSTOLE (FLAT LINE), BUT THE SYSTEM ALARMED ASYSTOLE NONETHELESS. THE PT WAVEFORM SHOWED OVERLAP BETWEEN THE PACER AND THE BEATS WHICH CAN CAUSE THE ARRYTHMIA DETECTION SOFTWARE TO DISCOUNT TRUE BEATS, RESULTING IN AN ASYSTOLE ALARM, AS WAS THE CASE HERE. THE ARRHYTHMIA DETECTION SOFTWARE FILTERS OUT PACER SPIKES IN ITS BEAT DETECTION TO AVOID COUNTING THESE SPIKES AS BEATS. IF THE SOFTWARE COUNTED PACER SPIKES AS BEATS, THEN THE BEAT COUNTER WOULD BE OFF, OR, MORE SIGNIFICANTLY, WE COULD EXPERIENCE A SITUATION WHERE A PT'S PACER CONTINUED AFTER THE PT'S HEART HAS STOPPED AND THE SOFTWARE WOULD SEE THE PACER AS THE HEART BEAT. THUS THE FALSE ASYSTOLE ALARM TRIPPED AS A RESULT OF THE PACER FILTER REMOVING TRUE BEATS. A FALSE ALARM IS UNLIKELY TO CAUSE OR CONTRIBUTED TO AN ADVERSE EVENT. NEITHER IS AN UNCONFIRMED REPORT OF LOSS OF CONNECTION TO THE BEDSIDE MONITORS. THUS WE WOULD NOT HAVE REPORTED THESE ON AN MDR HAD THE CUSTOMER NOT REPORTED THESE TO THEIR LOCAL AUTHORITIES. WE CAME LATE TO THE REALIZATION THAT WE MUST REPORT EVEN WHEN A FOREIGN USER FACILITY REPORTS, WHICH IS WHY THIS REPORTS COMES BEYOND THE 30 DAYS FILING DEADLINE. (SEE ADD'L SCANNED PAGES).

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REP REPORTED TWO SEPARATE ISSUES. THE FIRST ISSUE WAS THAT THE ACUITY SYS LOST CONTACT WITH BEDSIDE PT MONITORS FOR AN INDETERMINATE TIME. THE SECOND ISSUE REPORTED WAS THAT ACUITY MADE ERRONEOUS ARRHYTHMIA ANALYSIS ALARM INDICATIONS. THE USER FACILITY SUBSEQUENTLY REPORTED THESE ISSUES TO ANOTHER COUNTRY REGULATORY AUTHORITIES. WE HAVE INCLUDED A COPY OF THAT REGULATORY FILING IN THIS MDR FOR REFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY SW 6.40.00

    Patients

    Seq Age Sex Outcome Treatment
    1 YR