BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 7190627 · Received January 15, 2018

    Report

    Report Number
    1218950-2018-00437
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Report Date
    January 3, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE WILL BE IMPLEMENTING THE FCO AT THE CUSTOMER SITE. FCO (B)(4)FCO(B)(4) FCO (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE APPLICATION WOULD FAIL WHEN TRANSFERRING PATIENTS. THERE WAS NO PATIENT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35898 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389

    Patients

    Seq Age Sex Outcome Treatment
    1