BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP20 INTELLIVUE PATIENT MONITOR

    MDR report key: 3945334 · Received May 7, 2014

    Report

    Report Number
    9610816-2014-00120
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Report Date
    April 14, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SPEAKER FAILED AND THERE WAS NO SOUND ON STARTUP. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274989 MP20 INTELLIVUE PATIENT MONITOR NONE MHX PHILIPS MEDICAL SYSTEMS M8001A

    Patients

    Seq Age Sex Outcome Treatment
    1