BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 6330177 · Received February 14, 2017

    Report

    Report Number
    1218950-2017-01007
    Event Type
    Death
    Date Received
    February 14, 2017
    Date of Event
    February 7, 2017
    Report Date
    February 8, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE MALFUNCTION OCCURRED. PER COMMUNICATIONS WITH THE RESPONSE CENTER ENGINEER (RCE), THE CUSTOMER ONLY WANTED THE DATA FOR THE PATIENT FILE. THE RCE STATED THAT THE CUSTOMER DOES NOT ALLEGE A DEVICE MALFUNCTION AND DOES NOT BELIEVE THAT THE DEVICE CONTRIBUTED TO THE PATIENT INCIDENT. THE CUSTOMER WAS ADVISED TO PRINT OUT THE DATA THEY WERE SEEKING. THE DEVICE IS STILL IN USE AT THE CUSTOMER SITE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED REQUESTING RETRIEVAL OF 12 HOURS OF ECG DATA ON A USB STICK FOLLOWING A PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110969 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 Death