BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP50 INTELLIVUE PATIENT MONITOR

    MDR report key: 2010135 · Received February 11, 2011

    Report

    Report Number
    9610816-2011-00082
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Report Date
    January 13, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER CALLED WITH A REQUEST TO TRACE THE USER WHO MAY HAVE TURNED THE ALARMS OFF. NO PT HARM WAS REPORTED. THERE IS NO INDICATION OF A DEVICE MALFUNCTION OR LABELING ISSUE. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO CONCERNING THIS EVENT 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 CALLED WITH A REQUEST TO TRACE THE USER WHO MAY HAVE TURNED THE ALARMS OFF. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP50 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8004A

    Patients

    Seq Age Sex Outcome Treatment
    1