BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMICAS VERICIS

    MDR report key: 1701409 · Received May 14, 2010

    Report

    Report Number
    1701409
    Event Type
    Malfunction
    Date Received
    May 14, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 14, 2010
    Manufacturer
    AMICAS, INC., DIV. MERGE HEALTHCARE
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE RECENTLY COMPLETED A CARDIOLOGY SYSTEM HARDWARE UPGRADE. THE VENDOR OPTED TO UPGRADE THE SYSTEM SOFTWARE AT THE SAME TIME. ABOUT 10 DAYS AFTER THE UPGRADE, IT WAS REPORTED THAT THE LOW DOSE STRESS REPORTS WERE NOT ABLE TO GENERATE A REPORT, AND PHYSICIANS WERE NOT ABLE TO COMPLETE AND SIGN REPORTS. THE SPECIFIC STATEMENT THAT WOULD NOT EMBED IN THE REPORT IS "LOW DOSE: THERE WERE NO REGIONAL WALL MOTION ABNORMALITIES." BECAUSE OF THIS, A REPORT WAS NOT GENERATED FOR A PATIENT AWAITING LIVER TRANSPLANTATION. ALTHOUGH THE DIAGNOSTIC TEST HAD BEEN COMPLETED, THE ANESTHESIOLOGIST WAS UNAWARE OF THIS BECAUSE OF THE SOFTWARE PROBLEM, AND AS A RESULT, THE PATIENT DID NOT RECEIVE A NEEDED ORGAN. THE VENDOR WAS NOTIFIED IMMEDIATELY AND RESOLVED THE SOFTWARE PROBLEM WITHIN TWO DAYS.====================== HEALTH PROFESSIONAL'S IMPRESSION======================GLITCH CAUSED BY SOFTWARE UPGRADE====================== MANUFACTURER RESPONSE FOR SOFTWARE, VERICIS======================THEY HAVE INDICATED THEY WILL BE REPORTING TO MEDWATCH

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMICAS VERICIS SOFTWARE, CARDIOLOGY REPORTING / IMAGE STORAGE LLZ AMICAS, INC., DIV. MERGE HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR