BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP20 INTELLIVUE PATIENT MONITOR

    MDR report key: 3823098 · Received April 30, 2014

    Report

    Report Number
    9610816-2014-00109
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 9, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 RECEIVED A SPEAKER FAILURE MESSAGE AND REQUESTED THE PART NUMBER FOR A REPLACEMENT SPEAKER ASSEMBLY FOR THE INTELLIVUE MP20. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259535 MP20 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8001A

    Patients

    Seq Age Sex Outcome Treatment
    1