BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP2

    MDR report key: 3770463 · Received March 5, 2014

    Report

    Report Number
    9610816-2014-00049
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Report Date
    February 21, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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 ALARM DID NOT SOUND AND GENERATES A FALSE WAVEFORM. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133495 INTELLIVUE MP2 MHX PHILIPS MEDICAL SYSTEMS M8102A

    Patients

    Seq Age Sex Outcome Treatment
    1