BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLDONE CARDIAC

    MDR report key: 845513 · Received March 2, 2007

    Report

    Report Number
    1318879-2007-00001
    Event Type
    Malfunction
    Date Received
    March 2, 2007
    Date of Event
    February 19, 2007
    Report Date
    March 2, 2007
    Manufacturer
    INFIMED, INC.
    Product Code
    JAA
    PMA / PMN Number
    963037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILS OF EVENT DISCUSSED VIA PHONE WITH CRAIG HANLEY, ON SITE GE SERVICE ENGINEER, 2/2007. INITIAL REPLAY OF PT IMAGES WAS FINE, AND DR WAS ABLE TO REVIEW AND MAKE DICTATION. THEN WHILE TRANSFERRING IMAGES TO CARDIAC WORK STATION, PT'S FILES WERE OVERWRITTEN BY KOST PT FILES. SOFTWARE CHANGE REQUEST.

    Description of Event or Problem · 1

    PT IMAGES DID NOT PROPERLY TRANSFER TO CWS (CARDIAC WORK STATION) RESULTING IN LOSS OF IMAGES IN PT FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLDONE CARDIAC RADIOLOGICAL IMAGE PROCESSING SYSTEM JAA INFIMED, INC. GOLDONE CARDIAC *

    Patients

    Seq Age Sex Outcome Treatment
    1 *