BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP2

    MDR report key: 1894235 · Received November 3, 2010

    Report

    Report Number
    9610816-2010-00707
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Report Date
    October 14, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K040357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHILIPS HAS NOT DETERMINED WHETHER OR NOT THE SPEAKER IS STILL AUDIBLE. THE VISUAL INOP WOULD BE OBVIOUS TO USERS. IN ABUNDANT CAUTION, WE WILL REPORT THIS AS A MALFUNCTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING 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 THEY RECEIVED A VISIBLE "SPEAKER MALFUNCTION" INOP. NO PT WAS HARMED AS A RESULT OF THIS ISSUE.

    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