BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE TELEMETRY SYSTEM

    MDR report key: 7728737 · Received July 27, 2018

    Report

    Report Number
    1218950-2018-06010
    Event Type
    Malfunction
    Date Received
    July 27, 2018
    Report Date
    June 28, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K041741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 REPORTED THAT THE ENTIRE HOSPITAL MONITORING SYSTEM WENT OFFLINE. WHILE PHILIPS DEVICES PROVIDE MITIGATION'S RELATED TO THE LOSS OF CENTRALIZED WIRELESS MONITORING (IE ¿NO CENTRAL MON¿ INOP, VISUAL AND AUDIBLE TONES, LOCAL MONITORING FOR MX40), A MALFUNCTION THAT LEADS TO THE LOSS OF MONITORING FOR NUMEROUS PATIENTS USING MIXED WIRELESS DEVICES MAY RESULT IN A DELAYED RESPONSE TO AN INDIVIDUAL PATIENT REQUIRING EMERGENT CARE. E MONITORING MULTIPLE PATIENTS. NO ADVERSE EVENT INVOLVING PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568100 INTELLIVUE TELEMETRY SYSTEM NA MHX PHILIPS MEDICAL SYSTEMS M4840A

    Patients

    Seq Age Sex Outcome Treatment
    1