BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX450 PT MONITOR

    MDR report key: 3981256 · Received June 20, 2014

    Report

    Report Number
    9610816-2014-00177
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Report Date
    June 14, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K130849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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 SAYS THAT THE MX450 INTELLIVUE PT MONITOR WAS GOING INTO STANDBY WITH NO USER INPUT. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364347 INTELLIVUE MX450 PT MONITOR MHX PHILIPS MEDICAL SYSTEMS 866062 (MX450

    Patients

    Seq Age Sex Outcome Treatment
    1