BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP20 INTELLIVUE PATIENT MONITOR

    MDR report key: 1813261 · Received August 18, 2010

    Report

    Report Number
    9610816-2010-00352
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Report Date
    July 21, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THEY RECEIVED A VISIBLE "SPEAKER MALFUNCTION" INOP MESSAGE. NO PATIENT WAS HARMED AS A RESULT OF THIS ISSUE. THE VISUAL INOP WOULD BE OBVIOUS TO USERS. IN ABUNDANT CAUTION, WE WILL REPORT THIS AS A MALFUNCTION. PHILIPS REPLACED THE SPEAKER ASSEMBLY AND VERIFIED THAT THE DEVICE PROVIDED AUDIO AND VISUAL ALARMS. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED A VISIBLE "SPEAKER MALFUNCTION" INOP MESSAGE BUT NO AUDIO ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP20 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8001A

    Patients

    Seq Age Sex Outcome Treatment
    1