BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 3253678 · Received July 17, 2013

    Report

    Report Number
    9610816-2013-00154
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    July 5, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERMITTENT SPEAKER MALFUNCTION ON THE SCREEN. WHEN THE BIOMED FOUND THE UNIT IN THE WARD WITH THE MESSAGE THERE WAS NO AUTO. WHEN THE BIOMED TOOK THE UNIT TO A DIFFERENT LOCATION, THE MESSAGE WAS GONE AND THE AUDIO WAS BACK AND NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332068 INTELLIVUE MULTI MEASUREMENT SERVER X2 MHX PHILIPS MEDICAL SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1