BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON CARDIOLOGY HEMO

    MDR report key: 1544129 · Received November 6, 2009

    Report

    Report Number
    9616760-2008-00001
    Event Type
    Malfunction
    Date Received
    November 6, 2009
    Date of Event
    September 23, 2009
    Report Date
    October 8, 2009
    Manufacturer
    MCKESSON ISRAEL LTD.
    Product Code
    DQK
    PMA / PMN Number
    K050561
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON EVALUATED THE AFFECTED SYSTEM, AND IDENTIFIED THE ROOT CAUSE OF THE EVENT. THE SYSTEM WAS CONFIGURED TO COLLECT LOG FILES FROM A SCHILLER ARGUS PRO PB-1000 MONITOR UNIT, AND THIS CONFIGURATION CAUSED THE 5 SECONDS DELAY IN DISPLAYING WAVEFORMS ON THE HORIZON CARDIOLOGY HEMO SYSTEM. MCKESSON'S SERVICE ENGINEER CHANGED THE CONFIGURATION OF THE SYSTEM, TESTED THE SYSTEM AND VERIFIED THAT THE REPORTED ISSUE WAS RESOLVED. NO OTHER CLINICAL SITES WERE CONFIGURED TO COLLECT LOG FILES FROM A SCHILLER ARGUS PRO PB-1000 MONITOR UNIT.

    Description of Event or Problem · 1

    ON (B)(6), 2009 MCKESSON'S REPRESENTATIVE RECEIVED A REPORT FROM (B)(6), THAT DURING A CATH PROCEDURE, THE HORIZON CARDIOLOGY SYSTEM DISPLAYED PATIENT'S WAVEFORMS IN 5 SECONDS DELAY APPROXIMATELY. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON CARDIOLOGY HEMO HEMODYNAMIC SYSTEM DQK MCKESSON ISRAEL LTD. HCH11

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR