BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE INFORMATION CENTER

    MDR report key: 10443120 · Received August 24, 2020

    Report

    Report Number
    1218950-2020-04891
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Report Date
    August 4, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARMS WERE SILENCED AT THE CENTRAL STATION (PIC IX). A PHILIPS CUSTOMER CARE SERVICE CENTER (CCSC) REPRESENTATIVE SPOKE TO THE CUSTOMER AND CLARIFIED THAT THE SPEAKER FOR THE PIC IX WAS NOT EMITTING SOUND. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909315 INTELLIVUE INFORMATION CENTER CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS M3155

    Patients

    Seq Age Sex Outcome Treatment
    1