BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALYSTO SERIES IV

    MDR report key: 771149 · Received October 19, 2006

    Report

    Report Number
    1039368-2006-00003
    Event Type
    Injury
    Date Received
    October 19, 2006
    Date of Event
    October 2, 2006
    Report Date
    October 2, 2006
    Manufacturer
    WITT BIOMEDICAL CORP
    Product Code
    MWI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PT HAD A STROKE DUE TO LOW BLOOD PRESSURE, THE SYSTEM FUNCTIONED AS INTENDED, THERE WAS NO DETERIORATION IN EFFECTIVENESS OF THE DEVICE AND THERE WAS NOT AN INADEQUACY IN THE LABELING OR DIRECTIONS FOR USE. IT IS NOT POSSIBLE TO RESTRICT THE USER TO THE HEMODYNAMIC MONITORING SCREEN ON ANY CALYSTO SYSTEM BECAUSE THERE ARE OTHER FEATURES THAT THE USER MAY NEED TO GET TO (I.E., CINE REVIEW, VITALS PAGE, ETC.) THE PCM WAS DESIGNED WITH THE MENUS IN THE MONITORING SCREEN SO THAT THE USER COULD PERFORM THEIR MOST COMMON TASKS (MONITORING AND MENU ENTRY) WITHOUT LEAVING THE MONITORING SCREEN. THE CUSTOMER CHOSE TO LEAVE THE MONITORING SCREEN AND DID NOT USE THE ALARMS AS STATED IN OUR IFU (INSTRUCTIONS FOR USE) IN THE PCM USER'S GUIDE. REV 8, PAGE XVIII, #36 WHICH STATES THAT "CALYSTO MONITORS PHYSIOLOGIC PARAMETERS AND PROVIDES VISUAL AND AUDIBLE ALARMS. IT IS NOT DESIGNED FOR UNATTENDED USE. ALARMS MAY BE ACTIVATED OR DEACTIVATED AT THE USER'S DISCRETION AND IT'S THE USER'S RESPONSIBILITY TO CONFIGURE AND ACTIVATE THE ALARMS FOR EACH PT." PAGE XXI, STATES "USER ADJUSTABLE ALARMS, BOTH VISUAL AND AUDIBLE, ALERT THE OPERATOR TO ANOMALOUS OCCURRENCES AND FACILITATE TIMELY RESPONSES. USE OF CALYSTO CENTRAL STATION AND PT CARE MONITORS IS NOT INTENDED WHERE UNATTENDED PT MONITORING IS DESIRED OR IN SITUATIONS WHERE ARRHYTHMIA DETECTION IS REQUIRED." THE SYSTEM FUNCTIONED AS INTENDED AND WAS MONITORING THE PT VITALS. THE CUSTOMER HAS STATED THAT "ALARMS WERE TURNED OFF AT THE TIME. NEW PROTOCOLS FOR MONITORING WERE SETUP AND ALARMS WILL ALWAYS BE USED TO AVOID MISSING VITAL SIGN CHANGES". THIS IS THE FIRST OCCURRENCE OF THIS NATURE REPORTED TO WITT BIOMEDICAL CORP TO DATE. THE ABOVE MENTIONED PROTOCOL CHANGES PUT IN PLACE BY THE ACCOUNT SHOULD PREVENT FUTURE INCIDENTS AT THIS SITE.

    Description of Event or Problem · 1

    THE USERS TURNED OFF BOTH DUAL SCREEN MONITORING AND ALARMS ON THE PCM. DURING POST PROCEDURE MONITORING, THE USER DID NOT RECOGNIZE THAT THE PT'S BP WAS DROPPING FOR A PERIOD OF 20 MIN AND THE PT EXPERIENCED A STROKE. PT HAS SINCE RECOVERED. REPORTED AS DEVICE CONTRIBUTED TO USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALYSTO SERIES IV DIGITAL PT CARE MONITOR MWI WITT BIOMEDICAL CORP PT CARE MONITOR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other