BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX800 PATIENT MONITOR

    MDR report key: 3932436 · Received April 2, 2014

    Report

    Report Number
    9610816-2014-00088
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Report Date
    March 28, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 A "SPEAKER MALFUNCTION" ALARM ON THE MX800. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200155 INTELLIVUE MX800 PATIENT MONITOR MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDICAL SYSTEMS 865240 (MX800)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown