BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP2

    MDR report key: 1812685 · Received August 13, 2010

    Report

    Report Number
    9610816-2010-00266
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Report Date
    July 14, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K040357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED A VISIBLE "SPEAKER MALFUNCTION" INOP. NO PATIENT WAS HARMED AS A RESULT OF THIS ISSUE. PHILIPS HAS NOT DETERMINED WHETHER OR NOT THE SPEAKER IS STILL AUDIBLE. THE VISUAL INOP WOULD BE VALUABLE TO USERS. IN ABUNDANT CAUTION, WE WILL REPORT THIS AS A MALFUNCTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO 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 MP2 MONITOR HAD GENERATED A VISIBLE "SPEAKER MALFUNC." INOP MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MP2 MHX PHILIPS MEDICAL SYSTEMS M8102A

    Patients

    Seq Age Sex Outcome Treatment
    1