BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPAX CV REPORTING

    MDR report key: 1376460 · Received May 6, 2009

    Report

    Report Number
    1225058-2009-00002
    Event Type
    Other
    Date Received
    May 6, 2009
    Date of Event
    April 20, 2009
    Report Date
    May 6, 2009
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT DEFECTIVE. THE ROOT CAUSE OF THE PROBLEM WAS THAT ONE STEP OF THE INSTALLATION PROCEDURE WAS NOT PROPERLY EXECUTED. MEASURES ARE BEING TAKEN TO PREVENT RECURRENCE.

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED AND DIAGNOSTIC IMAGING PROCEDURE (LOWER VENOUS DUPLEX ULTRASOUND) WAS PERFORMED. STUDY REPORT OF CLINICAL FINDINGS WAS COMPLETED ON AGFA IMPAX CV REPORTING MODULE. REPORT WAS FINALIZED AT 1751, INDICATING PRESENCE OF ACUTE DVT IN RIGHT PERONEAL AND POSTERIOR TIBIAL VEINS. ELECTRONIC COPY OF REPORT SENT TO HOSPITAL INFORMATION SYSTEM (HIS), WITH INCOMPLETE INFORMATION DISPLAYED; "HIS" REPORT INDICATED NO EVIDENCE OF ACUTE OR CHRONIC THROMBOSIS. DISCREPANCY BETWEEN AGFA IMPAX CV REPORT AND "HIS" NOT APPARENT UNTIL 1845. AS A RESULT, THERE WAS A DELAY IN THE APPLICATION OF APPROPRIATE THERAPY (HEPARIN INFUSION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPAX CV REPORTING OUTBOUND RESULTS MANAGEMENT LLZ AGFA HEALTHCARE CORP. HL-ORUL7W1P000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR