BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP50 INTELLIVUE PATIENT MONITOR

    MDR report key: 3170335 · Received May 28, 2013

    Report

    Report Number
    9610816-2013-00117
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Report Date
    May 2, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 REPORTED THAT THE SPEAKER IN HIS MONITOR FELL SILENT (NO AUDIO). NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233154 MP50 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8004A

    Patients

    Seq Age Sex Outcome Treatment
    1