BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAC

    MDR report key: 12224419 · Received July 26, 2021

    Report

    Report Number
    12224419
    Event Type
    Malfunction
    Date Received
    July 26, 2021
    Date of Event
    June 20, 2021
    Report Date
    June 28, 2021
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME INTO THE ED WITH CHEST PAIN AND PATIENT WAS ROOMED. PATIENT WAS HOOKED UP TO AN EKG AND IT WOULD NOT SCAN AFTER MULTIPLE ATTEMPTS AND THEN IT WOULD NOT BRING UP THE DATA AREA TO PLUG IN THE SPECIFICS OF THE PATIENT INFORMATION. WE HAD TO CLOSE THE EKG MACHINE TWICE TO REBOOT AND THEN RESTART. DELAY OF OBTAINING EKG WITH MALFUNCTIONING EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122237 MAC ELECTROCARDIOGRAPH DPS GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 5500 HD

    Patients

    Seq Age Sex Outcome Treatment
    1 16790 DA