BEUDAMED
    FDA Adverse Event Death Summary report: N

    HORIZON CARDIOLOGY

    MDR report key: 3121591 · Received May 15, 2013

    Report

    Report Number
    9616760-2013-00001
    Event Type
    Death
    Date Received
    May 15, 2013
    Date of Event
    April 5, 2013
    Report Date
    May 15, 2013
    Manufacturer
    MAKESSON ISRAEL LTD.
    Product Code
    LLZ
    PMA / PMN Number
    K112720
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PERFORMED AS INTENDED AND DESIGNED. MCKESSON'S INVESTIGATION REVEALED THAT A USER DID NOT FOLLOW THE CUSTOMER'S ESTABLISHED WORKFLOW OF ASSIGNING A PHYSICIAN USER GROUP TO THE PROCEDURE. THEREFORE THE PROCEDURE DID NOT APPEAR IN THE RELEVANT SEARCH RESULTS. THE PROCEDURE APPEARED IN THE "UN-FINALIZED PROCEDURES" REPORT GENERATED BY THE STATISTICAL REPORTING TOOL. THIS REPORT IS AUTOMATICALLY GENERATED TWICE WEEKLY AND DISTRIBUTED VIA E-MAIL TO THE ADMINISTRATOR USER. THE PROCEDURE COULD HAVE BEEN DISCOVERED BY REVIEWING THE STATISTICAL REPORT OR BY USING OTHER SEARCH CRITERIA SUCH AS "UN-FINALIZED" PROCEDURES.

    Description of Event or Problem · 1

    ON (B)(6) 2013, MCKESSON CUSTOMER SUPPORT REC'D A REPORT FROM (B)(6) HOSPITAL THAT AN ECHOCARDIOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2013 DID NOT SHOW UP IN THE PHYSICIAN SEARCH RESULTS. THE PT WAS DISCHARGED FROM CARE ON (B)(6) 2013 AND SUBSEQUENTLY PASSED AWAY. THE PROCEDURE WAS IDENTIFIED AND REVIEWED BY A PHYSICIAN ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215324 HORIZON CARDIOLOGY LLZ MAKESSON ISRAEL LTD. HC12.2

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death