BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP5

    MDR report key: 1811040 · Received August 10, 2010

    Report

    Report Number
    9610816-2010-00272
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Report Date
    July 12, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K093268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT AN INTELLIVUE MP5 MONITOR HAD GENERATED A VISUAL "SPEAKER MALF." INOP. THE AVAILABLE INFORMATION DOES NOT INDICATE WHETHER OR NOT THE SPEAKER HAD A FAILED AUDIO FUNCTION. NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS ISSUE. 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN INTELLIVUE MP5 MONITOR HAD GENERATED A VISUAL "SPEAKER MALF." INOP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1