BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 4232429 · Received October 23, 2014

    Report

    Report Number
    9610816-2014-00271
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Report Date
    October 1, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE SPO2 MEASUREMENT WAS INTERMITTENT AND DID NOT PROVIDE AN INOP. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674432 INTELLIVUE MULTI MEASUREMENT SERVER X2 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDICAL SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown