BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP50 INTELLIVUE PATIENT MONITOR

    MDR report key: 1973020 · Received January 21, 2011

    Report

    Report Number
    9610816-2011-00036
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Report Date
    December 28, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT ALARMS CANNOT BE HEARD FROM ONE ROOM TO ANOTHER. NO PATIENT HARM WAS REPORTED. THE LIMITED INFORMATION DOES NOT INDICATE THAT THERE WAS ANY MALFUNCTION OF THE DEVICE. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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 REPORTED THAT ALARMS CANNOT BE HEARD FROM ONE ROOM TO ANOTHER. NO PATIENT 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