BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCKESSON CARDIOLOGY HEMO

    MDR report key: 8022584 · Received October 31, 2018

    Report

    Report Number
    9616760-2018-00002
    Event Type
    Death
    Date Received
    October 31, 2018
    Date of Event
    October 10, 2018
    Report Date
    October 30, 2018
    Manufacturer
    CHANGE HEALTHCARE ISRAEL LTD.
    Product Code
    DQK
    UDI-DI
    80010939050027
    PMA / PMN Number
    K131497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE SYSTEM APPEARED TO BE UNRESPONSIVE, THE REPORTING FACILITY CONTACTED CHANGE HEALTHCARE'S CUSTOMER SUPPORT TEAM FOR ASSISTANCE REGARDING SYSTEM PERFORMANCE. THE REPORTED UNRESPONSIVENESS DID NOT OCCUR DURING THE PATIENT PROCEDURE. WHEN THE USER WAS EXITING THE CASE, THE MCKESSON CARDIOLOGY HEMO APPLICATION WAS SYNCHRONIZING DATA FROM THE WORKSTATION TO THE CENTRAL DB RESULTING IN THE APPLICATION APPEARING UNRESPONSIVE TO THE USER.

    Description of Event or Problem · 1

    THE REPORTING FACILITY INFORMED CHANGE HEALTHCARE THAT THE MCKESSON CARDIOLOGY HEMO APPLICATION APPEARED TO BE UNRESPONSIVE UPON EXITING A CASE IN THE SYSTEM FOLLOWING COMPLETION OF A PATIENT PROCEDURE. DURING THE PROCEDURE AND BEFORE EXITING THE CASE, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866437 MCKESSON CARDIOLOGY HEMO MCKESSON CARDIOLOGY HEMO DQK CHANGE HEALTHCARE ISRAEL LTD. 14.0 80010939050027

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Death