BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACELABS TELEMETRY MONITORING XHIBIT MONITORS WITH ARIATELE

    MDR report key: 8471229 · Received March 29, 2019

    Report

    Report Number
    MW5085474
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    March 18, 2019
    Report Date
    March 26, 2019
    Manufacturer
    SPACELABS HEALTHCARE, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS ON A CARDIOTHORACIC STEP DOWN UNIT WITH SPACELABS TELEMETRY MONITORING IN PLACE. PT EXPERIENCED VF ARREST THAT WAS NOTED ON UNIT TELEMETRY AND CENTRAL TELEMETRY. STAFF RESPONDED APPROPRIATELY AND PATIENT WAS TREATED EFFECTIVELY. IN CODE REVIEW, THERE WAS QUESTION AND CONCERN BY NURSES AND TELEMETRY STAFF IF AN ALARM OCCURRED AND THE ALARM WAS AUDIBLE. THIS WAS REPORTED TO SPACELABS. TO BE CERTAIN AUDIBLE ALARMS WERE ACTIVE A VFIB/VTACH ALARM WAS REPLICATED WITH A TEST PATIENT. SPACELAB MONITORING DID RECOGNIZE THIS LETHAL ARRHYTHMIA ON BOTH THE PATIENT AND THE TEST PATIENT, HOWEVER, THE CURRENT ALARM FOR LETHAL ARRHYTHMIAS ARE THE SAME ALARM (TONE, VOLUME AND SOUND) AS ALL OTHER NON-CRITICAL ALARMS. THIS IS NO DISTINGUISHING TONE THAT SEPARATES NOISES, LEADS OFF , LOW BATTERY TO VFIB/ VTACH/ASYSTOLE (LETHAL ARRHYTHMIAS). IT IS CRITICAL THAT A LETHAL ARRHYTHMIA IS NOT ONLY DETECTED CORRECTLY BUT ALARMS DIFFERENTLY TO ALLOW STAFF TO RESPOND APPROPRIATELY IN AN EMERGENCY MANNER TO DEFIBRILLATE AND PROVIDE CPR IN THE CRITICAL TIMEFRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260599 SPACELABS TELEMETRY MONITORING XHIBIT MONITORS WITH ARIATELE MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) MHX SPACELABS HEALTHCARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| O