BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE INFO CENTER IX

    MDR report key: 18355072 · Received December 19, 2023

    Report

    Report Number
    1218950-2023-00945
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    December 6, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT AND G3 DATE RECEIVED BY MANUFACTURER WERE CORRECTED FROM (B)(6) 2023 TO (B)(6) 2023. G4 510K WAS CORRECTED FROM K211900 TO K102495. AN ENGINEER WENT TO THE CUSTOMER'S SITE AND CHECKED THE CORRECT ALARM CONFIGURATION. THE ENGINEER PERFORMED TESTING USING A SIMULATOR AND ALL RED ALARMS APPEARED IN THE CONTROL PANEL. THE CENTRAL MONITORING WAS REBOOTED, TESTING CONFIRMED THE DEVICE IS FUNCTIONAL AND REMAINS IN USE AT THE CUSTOMER'S SITE. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE MONITOR DOES NOT REPORT THE ALARMS. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350461 INTELLIVUE INFO CENTER IX INTELLIVUE INFO CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866023

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown