BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE

    MDR report key: 16589859 · Received March 22, 2023

    Report

    Report Number
    16589859
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    February 28, 2023
    Report Date
    March 13, 2023
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    MHX
    UDI-DI
    00840682104784
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSE ATTEMPTED TO TAKE A BLOOD PRESSURE OF A PATIENT AND WAS UNABLE TO. ALSO REPLACED THE CUFF AND THE TUBING WITH THE SAME RESULT SO THE MODULE WAS TAKEN OUT OF SERVICE AND RETURNED TO THE MANUFACTURE FOR A WARRANTY REPAIR. MANUFACTURER RESPONSE FOR MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS), GE (PER SITE REPORTER). THEY REPLACED THE MAIN BOARD AND CALIBRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457016 GE MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. PATIENT DATA MODULE 00840682104784

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown