BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAC 5500

    MDR report key: 6085267 · Received November 8, 2016

    Report

    Report Number
    6085267
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    August 30, 2016
    Report Date
    November 2, 2016
    Manufacturer
    GENERAL ELECTRIC HEALTHCARE TECHNOLOGY
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUR GENERAL ELECTRIC MAC 5500 ECG MACHINE HAD ITS VOLTAGE GAIN CHANGED FROM 10MM/MV, ITS DEFAULT SETTING, TO 5MM/MV. THIS CHANGE WENT UNNOTICED THROUGH PRINTING. HAVING THE PRINTOUT OF THE ECG AT 5MM/MV MASKED AN ACUTE STEMI. THIS RESULTED IN A DELAY OF CARE. CARDIOLOGY WAS CONSULTED AND NOTED THAT THIS PATIENT EXPERIENCED A DECREASE IN LEFT VENTRICULAR FUNCTION, WHICH MAY HAVE BEEN AVOIDED WITH SOONER CARDIAC INTERVENTION. UPON FURTHER INSPECTION OF THE ECG UNIT WE RECOGNIZED THAT SETTINGS CAN BE CHANGED RELATIVELY EASILY. SIMPLY PRESSING THE F4 KEY, FOR EXAMPLE, PROMPTS THE USER TO SELECT THE VOLTAGE GAIN THEY WANT TO PROCEED AT. THIS CREATES A PROBLEM WHEN THE EC NURSE DOESN'T KNOW WHAT THE DEFAULT SETTINGS OF THE MACHINE ARE AND INCORRECTLY SELECTS THE WRONG SETTING. THE INCORRECT SETTING WILL REMAIN IN PLACE UNTIL IT IS EITHER CORRECTED BY AGAIN PRESSING THE F4 KEY AND SELECTING THE CORRECT SETTING, OR THE MACHINE IS POWERED DOWN AND THEN BOOTED BACK UP. THE DEFAULT SETTING DOES NOT RETURN WHEN A NEW PATIENT IS STARTED WITHIN THE MACHINE. WHEN DEFAULT SETTINGS HAVE BEEN CHANGED AND A USER ATTEMPTS TO PRINT AN ECG FORM THE UNIT WILL DISPLAY A POP UP ASKING THE USER TO VERIFY THE ECG SETTINGS. THIS POP UP AGAIN RELIES ON THE END USER KNOWING WHAT SETTINGS THE MACHINE SHOULD BE AT. AFTER THIS OCCURRED AT OUR FACILITY OUR EMERGENCY MEDICINE PHYSICIANS BECAME COGNIZANT OF THESE ERRORS AND VIGILANT ABOUT ENSURING THE CORRECT VOLTAGE GAIN WAS RUN. ONE PHYSICIAN INFORMED US THAT SINCE THIS EVENT, HE HAS CAUGHT THREE ADDITIONAL ECGS THAT WERE HANDED TO HIM FOR INTERPRETATION THAT WERE RUN AT THE INCORRECT SETTING. IN AN EFFORT TO STOP THIS FROM HAPPENING WE WANTED TO CREATE HARD-SET DEFAULTS THAT COULD ONLY BE CHANGED BY AUTHORIZED PERSONNEL. WE LEARNED THAT THIS CANNOT BE DONE WITH THESE MACHINES. WE THINK INCORPORATING A PASSWORD SCHEME INTO THE SOFTWARE TO PREVENT FRONT LINE STAFF FROM CHANGING DEFAULT SETTINGS ON THE ECG MACHINE WOULD MITIGATE THESE RISKS. PER THE HOSPITAL, LINES OF COMMUNICATION HAS BEEN OPENED WITH THE MANUFACTURER. THE MANUFACTURER INTENDS TO SHARE THIS FEEDBACK WITH THEIR R AND D ENGINEERING DEPARTMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737915 MAC 5500 ELECTROCARDIOGRAPH DPS GENERAL ELECTRIC HEALTHCARE TECHNOLOGY MAC 5500

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other