BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP90 INTELLIVUE PATIENT MONITOR

    MDR report key: 4250078 · Received August 21, 2013

    Report

    Report Number
    9610816-2014-00225
    Event Type
    Malfunction
    Date Received
    August 21, 2013
    Report Date
    August 4, 2014
    Manufacturer
    PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LOUDSPEAKER DOES NOT WORK ANYMORE AND THIS LEAD TO AN ADVERSE EVENT INVOLVING A PATIENT. PHILIPS WILL REPORT THIS ISSUE AS AN ADVERSE EVENT BASED ON THE CUSTOMER'S STATEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407215 MP90 INTELLIVUE PATIENT MONITOR COMPACT PATIENT MONITOR MHX PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN M8010A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown