BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSOLV CARDIOVASCULAR

    MDR report key: 2627477 · Received December 23, 2008

    Report

    Report Number
    1836517-2008-00001
    Event Type
    Malfunction
    Date Received
    December 23, 2008
    Date of Event
    October 14, 2008
    Report Date
    December 23, 2008
    Manufacturer
    PROBLEM SOLVING CONCEPTS, INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON NOTIFICATION BY THE CUSTOMER SITE, THE COMPANY IMMEDIATELY INITIATED AN INVESTIGATION TO DETERMINE THE FULL EXTENT OF THE DEFECT. IT WAS DETERMINED THAT THE ISSUE WAS INTRODUCED INTO THE SOFTWARE BEGINNING WITH VERSION 3.5.1530 WHICH WAS RELEASED ON (B)(4) 2007. DESPITE THIS FACT, THIS IS THE FIRST REPORT OF THE ISSUE BEING MANIFESTED BY ANY CUSTOMER SITE. IN THE CASE DESCRIBED IN THIS FORM, THE EXPORT WOULD CONTAIN THE INCORRECT PT DEMOGRAPHICS (I.E., NAME/DATE OF STUDY) DISPLAY AS AN OVERLAY ON THE IMAGES. WITH RESPECT TO ULTRASOUND (ECHOCARDIOGRAPHY AND VASCULAR) AND NUCLEAR CARDIOLOGY IMAGES, THE PT DEMOGRAPHICS ARE EMBEDDED IN THE EXPORTED IMAGE BY THE SENDING DEVICE, SO UPON INSPECTION A USER SHOULD NOTICE THE INCORRECT DEMOGRAPHICS. FOR CARDIAC CATHETERIZATION IMAGES, THERE IS NO OTHER PT IDENTIFYING INFO ON THE EXPORTED IMAGE. BASED UPON THE FOREGOING, AND BEGINNING (B)(4) 2008, THE COMPANY CONTACTED ALL CUSTOMER SITES USING AFFECTED VERSIONS OF PROSOLV CARDIOVASCULAR IN A CARDIAC CATHETERIZATION LAB ENVIRONMENT TO PROVIDE NOTIFICATION OF THE ISSUE AND TO DESCRIBE THE PROPER PREVENTATIVE ACTION (I.E., USERS MUST ONLY HAVE ONE STUDY LOADED AND VIEWED WHEN EXPORTING TO CD/DVD). A FOLLOW-UP LETTER WAS SENT TO THESE CUSTOMER SITES, WITH PROOF OF RECEIPT. A SIMILAR LETTER WILL BE SENT TO ALL OTHER AFFECTED SITES (I.E., CUSTOMER SITES THAT ARE NOT USING PROSOLV CARDIOVASCULAR IN A CARDIAC CATHETERIZATION LAB ENVIRONMENT) WITHIN THE NEXT FIVE (5) BUSINESS DAYS. A SOFTWARE PATCH FOR THE AFFECTED VERSIONS, VERSIONS 3.5.1530, 3.5.1776 AND 4.0.142, IS TARGETED FOR RELEASE ON OR BEFORE (B)(4) 2009, AND WILL BE LABELED AS PROSOLV CARDIOVASCULAR 3.5.1530.12, PROSOLV CARDIOVASCULAR 3.5.1776.28 AND PROSOLV CARDIOVASCULAR 4.0.142.57 RESPECTIVELY. ONCE RELEASED, THESE SOFTWARE PATCHES WILL BE OFFERED AND DEPLOYED TO ALL AFFECTED CUSTOMER SITES.

    Description of Event or Problem · 1

    NO ADVERSE EVENT, MISDIAGNOSIS, OR PATIENT MISMANAGEMENT HAS BEEN REPORTED. HOWEVER, A CUSTOMER SITE HAS NOTIFIED PROSOLV CARDIOVASCULAR THAT IT DETECTED A SOFTWARE DEFECT WITH ITS CARDIOLOGY PACS SOFTWARE WHEN EXPORTING A PT'S DIAGNOSTIC IMAGES TO A CD. SUBSEQUENTLY, WE DETERMINED THERE IS A REMOTE POTENTIAL OF A POSSIBLE ADVERSE EVENT IF THIS DEFECT WAS ENCOUNTERED AND WENT UNDETECTED BY A USER AT ANOTHER SITE. THE CUSTOMER SITE REPORTED AN ISSUE WITH THE "(B)(4) STUDY" FEATURE OF THE COMPANY'S CARDIOLOGY PACS MEDICAL SOFTWARE WHEN MORE THAN ONE PT IS LOADED AND BEING VIEWED ON THE PROSOLV CARDIOVASCULAR CLIENT SOFTWARE APPLICATION. IF AN IMAGE FOR PT #1 IS LOADED AND BEING VIEWED ON THE PROSOLV CARDIOVASCULAR CLIENT SOFTWARE APPLICATION AND THE USER LOADS AN IMAGE OF PT #2 TO EXPORT CD/DVD, THE CLIENT SOFTWARE EXPORTS THE IMAGE OF PT #1 INSTEAD OF THE IMAGE FOR PT #2, BUT LABELS IT AS BELONGING TO PT #2. THE ISSUE WAS IDENTIFIED BY THE CUSTOMER SITE, A TEACHING INSTITUTION, WHILE PREPARING A CD/DVD FOR A CASE PRESENTATION FOR A CARDIOLOGY FELLOW (PHYSICIAN IN TRAINING). THERE WAS NO CLINICAL IMPACT DUE TO THE FACT THE ISSUE WAS IDENTIFIED PRIOR TO THE USE OF THE CD AND IT WAS TO BE USED FOR TEACHING PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSOLV CARDIOVASCULAR PROSOLV CARDIOVASCULAR LLZ PROBLEM SOLVING CONCEPTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1