BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE XDS

    MDR report key: 2221929 · Received August 17, 2011

    Report

    Report Number
    9610816-2011-00483
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    August 2, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K082633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THERE WAS A SPEAKER MALFUNCTION. IN ABUNDANCE OF CAUTION, WE WILL REPORT AUDIO LOSS EVEN THOUGH A VISUAL WARNING IS PROVIDED. NO PT HARM WAS REPORTED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A SPEAKER MALFUNCTION. IN AN ABUNDANCE OF CAUTION, WE WILL REPORT AUDIO LOSS EVEN THOUGH A VISUAL WARNING IS PROVIDED. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE XDS MHX PHILIPS MEDICAL SYSTEMS 865159

    Patients

    Seq Age Sex Outcome Treatment
    1