BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE X3

    MDR report key: 9834392 · Received March 16, 2020

    Report

    Report Number
    9610816-2020-00090
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Report Date
    March 6, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838082588
    PMA / PMN Number
    K171801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPEAKER MALFUNCTION. A SPEAKER MALFUNCTION NOP WAS DISPLAYED ON THE INTELLIVUE X3 AND NO SOUND WAS COMING FROM THE DEVICE. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301642 INTELLIVUE X3 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDICAL SYSTEMS 867030 00884838082588

    Patients

    Seq Age Sex Outcome Treatment
    1