BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCKESSON CARDIOLOGY HEMO

    MDR report key: 6415275 · Received March 17, 2017

    Report

    Report Number
    9616760-2017-00001
    Event Type
    Death
    Date Received
    March 17, 2017
    Date of Event
    February 28, 2017
    Report Date
    March 12, 2018
    Manufacturer
    CHANGE HEALTHCARE ISRAEL LTD.
    Product Code
    DQK
    PMA / PMN Number
    K131497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS ONGOING TO DETERMINE THE ROOT CAUSE OF THE ECG WAVEFORMS NOT DISPLAYING ON THE REAL TIME MONITOR. A FOLLOW-UP REPORT WILL BE SUBMITTED TO THE FDA UPON CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CHANGE HEALTHCARE HAS IDENTIFIED AN ISSUE WHERE, UNDER CERTAIN CONDITIONS, THE REAL TIME MONITOR (RTM) MAY NOT DISPLAY PHYSIOLOGICAL SIGNALS. THIS ISSUE MAY OCCUR WHEN A USER SELECTS A PATIENT FROM THE PATIENT LIST, AND THE ASSOCIATED PATIENT RECORDS INCLUDE AN UNUSUALLY HIGH NUMBER OF PROCEDURES. THIS ISSUE MAY CAUSE A BLANK OR INTERMITTENT DISPLAY ON THE RTM. CHANGE HEALTHCARE HAS DEVELOPED SOFTWARE UPDATES TO ADDRESS THE PROBLEM. ALTHOUGH THE ECG WAVEFORMS WERE NOT DISPLAYED ON THE RTM DURING THE EMERGENCY PROCEDURE, THE PATIENT'S ECG WAVEFORMS WERE MONITORED USING A DEFIBRILLATOR DURING THE DURATION OF THE PROCEDURE. THE CUSTOMER INDICATED THAT THE LACK OF THE DISPLAY OF THE ECG WAVEFORM WAS NOT THE CAUSE OF THE PATIENT OUTCOME. IN ADDITION, CHANGE HEALTHCARE WILL WORK WITH POTENTIALLY AFFECTED CUSTOMERS TO APPLY A SOFTWARE UPDATE TO PREVENT THE RECURRENCE OF THE PROBLEM. PLEASE NOTE THAT THE COMPANY NAMES HAVE CHANGED SINCE THE INITIAL MDR. MCKESSON (B)(4) LTD. IS NOW CHANGE HEALTHCARE (B)(4) LTD. AND MCKESSON TECHNOLOGIES LLC IS NOW CHANGE HEALTHCARE TECHNOLOGIES, LLC.

    Description of Event or Problem · 1

    PRIOR TO COMMENCING AN EMERGENCY CASE ON A PATIENT EXHIBITING HEART ARRHYTHMIA, THE ECG WAVEFORMS ON THE MCKESSON CARDIOLOGY HEMO RTMONITOR WENT BLANK. THE USER SWITCHED TO USING A DEFIBRILLATOR TO MONITOR ECG WAVEFORMS FOR COMMENCING AND MONITORING THE PROCEDURE. DURING INSERTION OF A TEMPORARY PACEMAKER, THE PATIENT EXPIRED.

    Description of Event or Problem · 1

    PRIOR TO COMMENCING AN EMERGENCY CASE ON A PATIENT EXHIBITING HEART ARRHYTHMIA, THE ECG WAVEFORMS ON THE MCKESSON CARDIOLOGY HEMO RTMONITOR WENT BLANK. THE USER SWITCHED TO USING A DEFIBRILLATOR TO MONITOR ECG WAVEFORMS FOR COMMENCING AND MONITORING THE PROCEDURE. DURING INSERTION OF A TEMPORARY PACEMAKER, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196758 MCKESSON CARDIOLOGY HEMO MCKESSON CARDIOLOGY HEMO DQK CHANGE HEALTHCARE ISRAEL LTD. MC 13.0 HF 3

    Patients

    Seq Age Sex Outcome Treatment
    1 Death