BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 2935533 · Received January 4, 2013

    Report

    Report Number
    9610816-2013-00006
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 4, 2012
    Manufacturer
    PHILIPS MEDICLA SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN X2 DEVICE FELL AND THEY LOST SCREEN AND TOUCHSCREEN CAPABILITY. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5639 INTELLIVUE MULTI MEASUREMENT SERVER X2 MHX PHILIPS MEDICLA SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1