BEUDAMED
    FDA Adverse Event Death Summary report: N

    CHANGE HEALTHCARE CARDIOLOGY HEMO

    MDR report key: 9731301 · Received February 20, 2020

    Report

    Report Number
    9616760-2020-00002
    Event Type
    Death
    Date Received
    February 20, 2020
    Date of Event
    January 22, 2020
    Report Date
    May 27, 2020
    Manufacturer
    CHANGE HEALTHCARE ISRAEL LTD
    Product Code
    DQK
    UDI-DI
    17540262100020
    PMA / PMN Number
    K131497
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTING FACILITY STATED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE DEATH OF THE PATIENT. INITIAL INVESTIGATION REVEALED THE ROOT CAUSE OF THE REPORTED MALFUNCTION IS ASSOCIATED WITH THE HARDWARE COMPONENTS OF THE DEVICE, AS THE HARDWARE COMPONENTS WERE REPLACED, AND NO RECURRENCE OF THIS INCIDENT WAS REPORTED BY THE REPORTING FACILITY. TESTING OF PB-1000, ONE OF THE HARDWARE COMPONENTS ASSOCIATED WITH THE FAILURE, CONCLUDED THAT IT IS WITHIN ITS SPECIFICATIONS. THE OTHER HARDWARE COMPONENT (CU) WAS NOT RECEIVED BY CHANGE HEALTHCARE, DESPITE A REPLACEMENT UNIT THAT WAS SENT TO THE CUSTOMER. MULTIPLE FOLLOW UP ATTEMPTS WERE MADE BY PHONE AND BY EMAIL. THEREFORE, THE CU COMPONENT ASSOCIATED WITH THE FAILURE WAS NOT INSPECTED. DUE TO THE ABOVE, TO DATE, CHANGE HEALTHCARE CANNOT DETERMINE THE ROOT CAUSE OF THE FAILURE. IF ADDITIONAL INFORMATION WILL BE OBTAINED, CHANGE HEALTHCARE WILL FOLLOW UP WITH FDA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE IN THE CATHETERIZATION LAB INVOLVING A PATIENT IN FULL CARDIAC ARREST UNDERGOING CPR, DEFIBRILLATION, AND ARTIFICIAL VENTILATION, THAT THE RT MONITOR WENT BLANK MULTIPLE TIMES AND REBOOTED FOR SEVERAL SECONDS AND RETURNED TO FULL FUNCTIONALITY. DURING THE PROCEDURE AND THE REPORTED RT MONITOR BLANKING OUT EVENTS, AS INDICATED IN THE DEVICE INSTRUCTIONS FOR USE AUXILIARY DEVICES WERE USED TO MONITOR THE PATIENT'S VITAL SIGNS. SUBSEQUENT TO THE PROCEDURE THE PATIENT EXPIRED.

    Additional Manufacturer Narrative · 1

    THE REPORTING FACILITY STATED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE DEATH OF THE PATIENT. INITIAL INVESTIGATION REVEALED THE ROOT CAUSE OF THE REPORTED MALFUNCTION IS ASSOCIATED WITH THE HARDWARE COMPONENTS OF THE DEVICE. THE HARDWARE COMPONENTS WERE REPLACED, AND THEN MONITORED BY THE REPORTING FACILITY. THE REPORTING FACILITY CONFIRMED THE RT MONITOR IS WORKING AS DESIGNED SINCE THE REPLACEMENT. THE HARDWARE ASSOCIATED WITH THE FAILURE IS UNDER FURTHER INVESTIGATION. CHANGE HEALTHCARE WILL PROVIDE A FOLLOW UP REPORT TO THE AGENCY ONCE ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE IN THE CATHETERIZATION LAB INVOLVING A PATIENT IN FULL CARDIAC ARREST UNDERGOING CPR, DEFIBRILLATION, AND ARTIFICIAL VENTILATION, THAT THE RT MONITOR WENT BLANK MULTIPLE TIMES AND REBOOTED FOR SEVERAL SECONDS AND RETURNED TO FULL FUNCTIONALITY. DURING THE PROCEDURE AND THE REPORTED RT MONITOR BLANKING OUT EVENTS, AS INDICATED IN THE DEVICE INSTRUCTIONS FOR USE AUXILIARY DEVICES WERE USED TO MONITOR THE PATIENT'S VITAL SIGNS. SUBSEQUENT TO THE PROCEDURE THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197991 CHANGE HEALTHCARE CARDIOLOGY HEMO CHANGE HEALTHCARE CARDIOLOGY HEMO DQK CHANGE HEALTHCARE ISRAEL LTD 14.1.1 17540262100020

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death