BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18301541 · Received December 8, 2023

    Report

    Report Number
    MW5149058
    Event Type
    Injury
    Date Received
    December 8, 2023
    Report Date
    December 6, 2023
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPACELABS XPREZZON/QUBE MONITORS (SW: 3.08.02) WHEN USED WITH COMMAND MODULE 91496 (SW: 2.07.00) DEFAULT TO ALLOW USERS THE CAPABILITY TO TURN OFF ALL ECG (ELECTROCARDIOGRAM) ALARMS INCLUDING LETHAL ARRYTHMIA'S VFIB (VENTRICULAR FIBRILLATION) AND ASYSTOLE. IF USERS ARE NOT AWARE OF THIS, THEY COULD TURN ECG (ELECTROCARDIOGRAM) ALARMS OFF AND POTENTIALLY MISS LETHAL ARRYTHMIAS. SPACELABS NEEDS TO UPDATE THEIR SOFTWARE SO THAT THE "ALARM CONTROL" SETTING IN THE 91496 SETTINGS IS DEFAULTED TO OFF. REFERENCE REPORTS: MW5149056, MW5149057.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75861 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX SPACELABS HEALTHCARE INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening