BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPAX CV REPORTING

    MDR report key: 2549029 · Received April 19, 2012

    Report

    Report Number
    1225058-2012-00009
    Event Type
    Other
    Date Received
    April 19, 2012
    Date of Event
    January 16, 2012
    Report Date
    April 19, 2012
    Manufacturer
    AGFA HEALTHCARE CORP
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE REPORT OF THE PT STUDY REPORT TO THE HIS, THE REPORT OF PT A (DEMOGRAPHICS AND FINDINGS OF PT A) WAS SOMETIMES ASSIGNED TO A DIFFERENT PT B. IN THIS EVENT, A PT RECEIVED THE REPORT OF ANOTHER PT. THE ROOT CAUSE OF THIS EVENT IS CURRENTLY UNK, AS INVESTIGATION CONTINUES TO ADDRESS THE ISSUE. THE SITE'S RN AND SENIOR ANALYST IN CLINICAL APPLICATIONS STATED THERE HAD BEEN NO IMPACT ON PT CARE DUE TO THIS EVENT. SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ROOT CAUSE AND CORRECTIVE ACTION IS DETERMINED.

    Description of Event or Problem · 1

    PT STUDY REPORT IS INTERMITTENTLY EXPORTED TO THE WRONG PT WITHIN HIS. REPORT WAS CREATED IN IMPAX CV REPORTING AND CONVERTED INTO ADOBE ACROBAT PDF VERSIONS, (VIA A 3RD PARTY TOOL CALLED (B)(4)) FOR PRESENTATION IN IMPAX CV REPORTING AND THE HOSPITAL'S INFO SYSTEM (HIS). AFTER THE REPORT OF THE REPORT TO THE HIS, THE REPORT OF PT A (DEMOGRAPHICS AND FINDINGS OF PT A) WAS SOMETIMES ASSIGNED TO A DIFFERENT PT B. IN THIS EVENT, A PT RECEIVED THE REPORT OF ANOTHER PT. THE ROOT CAUSE OF THIS EVENT IS CURRENTLY UNK, AS INVESTIGATION CONTINUES TO ADDRESS THE ISSUE. THE SITE'S RN AND SENIOR SYSTEM ANALYST IN CLINICAL APPLICATIONS STATED THERE HAS BEEN NO IMPACT ON PT CARE DUE TO THIS EVENT. SUPPLEMENTAL REPORTING WILL BE SUBMITTED ONCE ROOT CAUSE AND CORRECTIVE ACTION IS DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPAX CV REPORTING SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ AGFA HEALTHCARE CORP CV SUITE 7.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1