BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP5

    MDR report key: 2042843 · Received March 30, 2011

    Report

    Report Number
    9610816-2011-00171
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Report Date
    March 17, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K091395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE MONITOR GENERATED A VISUAL "SPEAKER MALF." INOP. NO PT HARM WAS REPORTED. THE PHILIPS FIELD SERVICE ENGINEER VERIFIED THAT THERE WAS A LOSS OF AUDIO FUNCTION, AND SPEAKER REPLACEMENT RESOLVED THE PROBLEM. THE DEVICE LABELING ADEQUATELY WARNS USERS NOT TO RELY SOLELY ON AUDIBLE ALARMING AND SPECIFIES CLOSE PERSONAL OBSERVATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE MONITOR GENERATED A VISUAL "SPEAKER MALF." INOP. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MP5 MHX PHILIPS MEDICAL SYSTEMS M8105A (865024)

    Patients

    Seq Age Sex Outcome Treatment
    1