BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP30 INTELLIVUE PATIENT MONITOR

    MDR report key: 1983727 · Received February 4, 2011

    Report

    Report Number
    9610816-2011-00045
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Report Date
    January 13, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHILIPS IS REPORTING THIS EVENT ONLY BECAUSE WE DO NOT HAVE ENOUGH INFORMATION TO DETERMINE WHETHER THERE WAS ANY LOSS OF AUDIO FUNCTION AND THEREFORE ANY HEALTH RISK. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIS MP30 HAS A "SPEAKER MALF" INOP MESSAGE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP30 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8002A

    Patients

    Seq Age Sex Outcome Treatment
    1