BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 3170339 · Received May 28, 2013

    Report

    Report Number
    9610816-2013-00116
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Report Date
    May 22, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 A SPEAKER ON X2 HAS FAILED AND IS COMPLETELY OUT OF SOUND. CUSTOMER RECEIVED THE "SPEAKER MALFUNCTION" INOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233249 INTELLIVUE MULTI MEASUREMENT SERVER X2 MHX PHILIPS MEDICAL SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1