BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELIVUE TELEMETRY SYSTEM

    MDR report key: 3897034 · Received May 16, 2014

    Report

    Report Number
    1218950-2014-02724
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Report Date
    April 23, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K041741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR WIRELESS SYSTEM WAS DOWN. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294714 INTELIVUE TELEMETRY SYSTEM MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDICAL SYSTEMS M4840A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown