BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCOTT CARE

    MDR report key: 508858 · Received January 20, 2004

    Report

    Report Number
    MW1030912
    Event Type
    Malfunction
    Date Received
    January 20, 2004
    Report Date
    January 20, 2004
    Manufacturer
    SCOTT CARE
    Product Code
    DRG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CARDIAC REHAB DEPARTMENT AT STATE OF ART TELEMETRY SYSTEM INSTALLED BY SCOTTCARE. THE STAFF ANTICIPATED GREAT ADVANCES WITH THE NEW TECHNOLOGY, BUT RATHER HAVE BECOME DISILLUSIONED WITH THE SOFTWARE AND UNTRUSTING OF THE CORRUPTED DATA THAT IT COMPILES. AFTER INSTALLATION, THE STAFF NOTED TARGET HEART RATES (PRESCRIPTION DATA) THAT WERE ENTERED WERE LOST, ERRONEOUS HIGH HEART RATES, MOUSE MOVEMENT CAUSED THE SYSTEM TO CRASH WITH MULTIPLE ERROR CODES, UNACCEPTABLE LEVELS OF ARTIFACT, INTERMITENT STRIP CHART PRINTER FAILURES, SYSTEM CRASHES WITH MONITORED PTS EXERCISING, LOST DATA, INTERMITTENT PRESCRIPTION CHANGES, AND MORE. COMMUNICATED THESE PROBLEMS TO THE SALES REP, AND THE SERVICE MANAGER. THEIR RESPONSE WAS REASONABLE, BUT WITHOUT SATISFACTORY RESOLUTION. IN 2004, AN UPGRADE WAS INSTALLED. SINCE INSTALLATION OF THE UPGRADE, STAFF HAS CONTINUED TO EXPERIENCE REPEATED SYSTEM CRASHES, LOSS OF TARGET HEART RATE DATA, DATA FROM TWO DIFFERENT PTS IN ONE REPORT, FRAGMENTED REPORTS WITH RHYTHM STRIPS OR MODALITY DATA MISSING, PT NAME LOST FROM THE SYSTEM WITH THEIR DATA UNAVAILABLE, DUPLICATION OF PT DATA FILES, DATA TRANSPOSITION ON REPORTS, AND MORE. AS A RESULT OF THESE PROBLMES, STAFF IS APPREHENSIVELY SIGNING DAILY SESSION REPORTS. TODAY, A PHYSICIAN REFUSED TO SIGN A PT EXERCISE REPORT DUE TO CORRUPT, UNVERIFIABLE REPORT DATA. THIS IS UNACCEPTABLE LIABILITY EXPOSURE FOR THE STAFF AND HOSPITAL. HOSP'S EXPECTATION IN THE HEALTH CARE INDUSTRY IS THAT NEW HEALTHCARE SOFTWARE HAS BEEN APPROVED BY AN APPROPRIATE AUTHORITY, THE FOOD AND DRUG ADMINISTRATION, BUT HOSP'S EXPERIENCE WITH THIS SOFTWARE BEGS THE QUESTION THAT PERHAPS THE AUTHORITY DOES NOT HAVE ALL OF THE FACTS PERTAINING TO THIS SOFTWARE. THE REPEATED SOFTWARE SYSTEM FAILURES AND CORRUPTED DATA/FILES RESULT IN PT SAFETY CONCERNS, AND PT SAFETY CONCERNS LEAD TO LIABILITY CONCERNS FOR THE STAFF AND THE HOSP. IN SUMMATION REPORTER FEELS THIS SOFTWARE SYSTEM IS UNSAFE, UNRELIABLE AND NOT READY FOR USE BY THE HEALTHCARE INDUSTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCOTT CARE ADVANTAGE TELEMETRY MONITORING FOR CARDIAC REHAB DRG SCOTT CARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *