BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

    MDR report key: 15492158 · Received September 27, 2022

    Report

    Report Number
    15492158
    Event Type
    Malfunction
    Date Received
    September 27, 2022
    Date of Event
    May 25, 2022
    Report Date
    September 12, 2022
    Manufacturer
    GE HEALTHCARE, LLC
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE TELEMETRY MONITOR, CARESCAPE MONITOR B650, WAS READING THE PATIENT'S HEART RATE AS 60-80¿THIS IS EXTREMELY LOW FOR AN INFANT. WHEN HIS HEAR RATE WAS AUSCULTATED, IT WAS BETWEEN 190-200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2304142 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX GE HEALTHCARE, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 365 DA Male