BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 4240029 · Received May 28, 2014

    Report

    Report Number
    9610816-2014-00149
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Report Date
    May 14, 2014
    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 THAT THE X2 DISPLAYS THE INOP "LOUDSPEAKER ERROR." THERE IS NO AUDIBLE SOUND. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315161 INTELLIVUE MULTI MEASUREMENT SERVER X2 MHX PHILIPS MEDICAL SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1