BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP2

    MDR report key: 3891926 · Received February 10, 2014

    Report

    Report Number
    9610816-2014-00025
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Report Date
    January 16, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED A SPEAKER MALFUNCTION. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED AND NO PATIENT OR USER WAS HARMED. THE SPEAKER MALFUNCTION WITH LOSS OF AUDIO SOUND WAS CONFIRMED BY THE PHILIPS FIELD SERVICE ENGINEER (FSE) WHO WENT TO THE CUSTOMER SITE. THE FSE REPLACED THE SPEAKER. PRODUCT LABELING SHIPPED WITH THE DEVICE CLEARLY WARNS NOT TO RELY EXCLUSIVELY ON THE AUDIBLE ALARM SYSTEM FOR PATIENT MONITORING. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPEAKER MALFUNCTION. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88768 INTELLIVUE MP2 MHX MHX PHILIPS MEDICAL SYSTEMS M8102A

    Patients

    Seq Age Sex Outcome Treatment
    1