BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE HEALTHCARE

    MDR report key: 7788571 · Received August 16, 2018

    Report

    Report Number
    7788571
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    August 9, 2018
    Report Date
    August 13, 2018
    Manufacturer
    GE HEALTHCARE
    Product Code
    OUG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DATA INTERFACE UNIT (CIC) FOR GE AT THE CENTRALIZED TELEMETRY FROZE UP, NOT ALLOWING THE NURSE/TECH TO CLICK OR PERFORM ANY ACTION ON THE DISPLAY. NOT ABLE TO ADMIT, REVIEW, OR ACCESS ANYTHING ON THE DISPLAY. STAFF WERE NOT ABLE USING THE MOUSE OR THE TOUCH SCREEN. ONCE THE DEVICE WAS RESTARTED, IT CAME BACK UP AND WORKED NORMALLY. THIS IS THE SECOND TIME THIS DEVICE CAUSES A SIMILAR PROBLEM. PREVIOUS INCIDENT, THE SAME DEVICE GAVE A "MEMORY ERROR" AND STOPPED TO WORK. PER SITE REPORTER: NO ANSWER FROM GE HEALTHCARE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630398 GE HEALTHCARE DATA INTERFACE UNIT - CIC OUG GE HEALTHCARE MAS700 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 36135 DA