BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 4250448 · Received November 7, 2014

    Report

    Report Number
    9610816-2014-00290
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Report Date
    October 14, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 UNIT WAS DROPPED AND WAS "SHOWING INCORRECT RESULT". IT IS UNK IF THE DEVICE WAS DROPPED OR IF IT FELL FROM A MOUNTING DEVICE. NO PATIENT OR USER HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719300 INTELLIVUE MULTI MEASUREMENT SERVER X2 MHX MHX PHILIPS MEDICAL SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown