BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS REMOTE TELEMETRY PACKS

    MDR report key: 4202589 · Received October 18, 2014

    Report

    Report Number
    4202589
    Event Type
    Death
    Date Received
    October 18, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 18, 2014
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD FEMALE S/P SYNCOPAL EPISODE AND FALL WITH WITNESSED SEIZURES - RULED OUT FOR TRAUMATIC INJURY. ADMITTED AND PLACED ON REMOTE TELEMETRY MONITORING FOR OBSERVATION AND ALCOHOL WITHDRAWAL PROTOCOL. THE PATIENT WAS MONITORED IN ATRIAL FIBRILLATION WITH VENTRICULAR RATE OF 100 - 150. APPROXIMATELY 24 HOURS AFTER ADMISSION, ON (B)(6) 2014, THE PATIENT WAS NOTED TO BE ANXIOUS AND DIAPHORETIC. THE STAFF WAS MADE AWARE OF ONE LEAD OFF AT 23:23:30; THE HEART RATE WAS 100. THE MONITOR ENTERED STANDBY AT 23:49:26 RELATED TO LEADS OFF. THE NURSING STAFF WAS NOTIFIED OF THE LEADS OFF CONDITION. A STAFF MEMBER RE-APPLIED THE LEADS. AT 23:54:58 THE CENTRAL STATION ALERTED THE NURSE TO LOW BATTERY. THE NURSING STAFF CHANGED THE BATTERY. AT 23:55:58 THE CENTRAL STATION WAS NOT RECEIVING A SIGNAL. THE CENTRAL STATION CONFIRMED A RHYTHM AT 23:58:27 WITH A VENTRICULAR RATE OF 20. THE NURSE WAS ALERTED AND ENTERED THE ROOM TO FIND THE PATIENT UNRESPONSIVE. RESUSCITATION OCCURRED AND THE PATIENT TRANSFERRED TO ICU FOR AGGRESSIVE TREATMENT WITH HYPOTHERMIA, ACIDOSIS, AND SEIZURES. THE PATIENT WAS DIAGNOSED WITH AN ANOXIC BRAIN INJURY AND SEIZURES. LIFE SUPPORT WAS REMOVED AND THE PATIENT EXPIRED ON (B)(6) 2014. MANUFACTURER NOTIFIED OF EVENT AND ON SITE ON (B)(6) 2014. MEDICAL EXAMINER CASE - AUTOPSY RESULTS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664132 PHILIPS REMOTE TELEMETRY PACKS (INTELLIVIEW MX40) MHX PHILIPS HEALTHCARE MX40-1B4

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death| S LITHIUM RECHARGEABLE BATTERY