BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS SURESIGNS VM

    MDR report key: 8416311 · Received March 13, 2019

    Report

    Report Number
    8416311
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    January 3, 2019
    Report Date
    January 11, 2019
    Manufacturer
    PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT'S CARDIAC MONITOR BEGAN TO ALARM V-TACH WITH A HEART RATE OF 160S-210S. LEADS WERE IN PROPER PLACE AND RHYTHM ON MONITOR APPEARED TO BE V-TACH. PATIENT ALERT, BP STABLE, RADIAL PULSE 104, DOCTOR AT BEDSIDE ORDERED DOSE OF IV CARDIZEM TO BE GIVEN. RN ATTACHED A SECOND MONITOR WITH MORE LEAD VISUALIZATION CAPABILITY AS IV CARDIZEM WAS TO BE GIVEN AND SECOND MONITOR SHOWED A SINUS TACHY RHYTHM WITH HR IN LOW 100S DESPITE FIRST CARDIAC MONITOR CONTINUING TO DISPLAY V-TACH WITH HR IN 200S. IV CARDIZEM NOT GIVEN, FIRST MONITOR TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210128 PHILIPS SURESIGNS VM MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)26 MHX PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA