BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE INFO CENTER IX

    MDR report key: 7591499 · Received June 12, 2018

    Report

    Report Number
    1218950-2018-04930
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Report Date
    May 24, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT MALFUNCTION WAS CONFIRMED BY A PHILIPS RESPONSE CENTER ENGINEER (RCE); THERE WAS NO SOUND FROM THE SPEAKER. THE DEVICE WAS TESTED BY THE CUSTOMER BIOMED USING A KNOWN WORKING SPEAKER ADAPTOR, AND IT WAS DETERMINED THAT THE SPEAKER ADAPTOR NEEDED TO BE REPLACED; THEREFORE, THE RCE PROVIDED INFORMATION TO THE BIOMED FOR ORDERING A REPLACEMENT SPEAKER ADAPTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SPEAKER ADAPTOR HAD ISSUES; THERE WAS NO SOUND FROM THE SPEAKER FOR THE DEVICE. IT WAS REPORTED THAT THERE WAS NO ADVERSE EVENT OR PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436426 INTELLIVUE INFO CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866023

    Patients

    Seq Age Sex Outcome Treatment
    1