BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV CARDIOVASCULAR REVIEW STATION

    MDR report key: 2467609 · Received January 7, 2012

    Report

    Report Number
    1225058-2012-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2012
    Date of Event
    December 8, 2011
    Report Date
    January 7, 2012
    Manufacturer
    AGFA HEALTHCARE CORP
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPAX CARDIOVASCULAR REVIEW STATION (CRS) ALLOWS FOR THE USER TO ACCESS PT STUDIES, AND TO OPEN THEN FOR IMAGE REVIEW AND CLINICAL INTERPRETATION. IN ADDITION TO THE REVIEW OF IMAGES WITHIN CRS, THE IMAGES CAN ALSO BE REVIEWED USING A 3RD PARTY¿S SOFTWARE SUCH AS INVIA CORRIDOR4DM. INVIA CORRIDOR4DM IS USED FOR QUANTIFICATION, FURTHER IMAGE REVIEW, AND REPORTING OF CARDIAC PERFUSION, FUNCTION AND ANATOMY IN NUCLEAR IMAGING. DICOM IMAGES ARE UNIQUELY IDENTIFIED (DICOM (DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE) IS A STANDARD FOR HANDLING, STORING, PRINTING, AND TRANSMITTING INFO IN MEDICAL IMAGING). PT DEMOGRAPHIC INFO IS EMBEDDED IN THESE IMAGES. THIS PT INFO IS DISPLAYED AS OVERLAYS ON BOTH IMPAX CRS AND INVIA CORRIDOR4DM. RATIONALE: TECHNICAL ANALYSIS HAS REVEALED THAT WHEN A USER IS NOT GRANTED PROPER RIGHTS ON A SPECIFIC FILE ((B)(4)) AND INVIA CORRIDOR4DM IS STARTED FROM CRS, CORRIDOR4DM DISPLAYS THE IMAGES FROM THE PREVIOUSLY SELECTED PT (PT A), INSTEAD OF THE CURRENT PT OPENED ON CRS (PT B). THE NET EFFECT IS THE PHYSICIAN REVIEWING THE IMAGES ON INVIA CORRIDOR4DM IS PRESENTED WRONG DATA. HOWEVER, FOR THE REASONS STATED ABOVE, THE IMAGES ARE CORRECTLY IDENTIFIED WITH THEIR ASSOCIATED PT DEMOGRAPHICS.

    Description of Event or Problem · 1

    WRONG PT INFO IS BEING DISPLAYED WHEN PHYSICIANS USE CRS AND THE INVIA CORRIDOR4DM TOOL WHEN A PT IS OPENED IN INVIA CORRIDOR4DM FROM IMPAX CRS, A DIFFERENT PT IS OPENED EVERY TIME. IMPACT ON PT CARE: THE CUSTOMER STATED THAT THERE WAS NO MISREAD OR IMPACT TO PT CARE BECAUSE THE SITE DID NOT USE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPAX CV CARDIOVASCULAR REVIEW STATION PICTURE ARCHIVING AND COMMUNICATIONS SYS LLZ AGFA HEALTHCARE CORP ALL VERSIONS

    Patients

    Seq Age Sex Outcome Treatment
    1