BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 7045358 · Received November 20, 2017

    Report

    Report Number
    1218950-2017-07939
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Report Date
    October 26, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED A PHILIPS CLINICAL SPECIALIST (CS) STATING A TELEMETRY (MX40 PWM) DEVICE LOST POWER WITH NO LOW BATTERY OR REPLACE BATTERY ALERT OR ALARM AND THE PATIENT WENT UNMONITORED FOR 60 MINUTES. THERE WAS NO REPORT OF PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826592 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389

    Patients

    Seq Age Sex Outcome Treatment
    1