BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCKESSON CARDIOLOGY HEMO

    MDR report key: 7488292 · Received May 4, 2018

    Report

    Report Number
    9616760-2018-00001
    Event Type
    Death
    Date Received
    May 4, 2018
    Date of Event
    March 8, 2018
    Report Date
    May 4, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEWS OF THE SYSTEM LOGS CONCLUDED THAT THE ALARMS WERE DISABLED BY THE USER. DISABLING OF THE ALARMS IS AN OPTIONAL USER FEATURE OF THE MCKESSON CARDIOLOGY HEMO APPLICATION. THE DEVICE OPERATED AS INTENDED AND DESIGNED WITH NO EVIDENCE OF A MALFUNCTION.

    Description of Event or Problem · 1

    THE REPORTING FACILITY CONTACTED CHANGE HEALTHCARE TO ASSIST IN AN INVESTIGATION INTO MCKESSON CARDIOLOGY HEMO - PHYSIOLOGICAL ALARMS DEACTIVATION INVOLVING A PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328634 MCKESSON CARDIOLOGY HEMO MCKESSON CARDIOLOGY HEMO DQK CHANGE HEALTHCARE ISRAEL LTD. 14.0 80010939050027

    Patients

    Seq Age Sex Outcome Treatment
    1 Death