BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 8934192 · Received August 27, 2019

    Report

    Report Number
    1218950-2019-06441
    Event Type
    Injury
    Date Received
    August 27, 2019
    Report Date
    August 25, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A PHILIPS RESPONSE CENTER ENGINEER (RCE) SPOKE TO THE CUSTOMER BIOMEDICAL ENGINEER (BIOMED). THE BIOMED STATED THAT THE NICU WAS MOVED FROM ONE LOCATION TO ANOTHER. THE RCE REMOTELY ACCESSED THE CUSTOMERS SYSTEM AND FOUND THAT NOT ALL CONFIGURATIONS WERE SET ON THE PIIC IX DEVICE FROM THE MOVE TO THE NEW AREA. THE RCE CONFIGURED THE ALARM NOTIFICATION OF BEDSIDE OVERVIEW SETTINGS TO STATUS BAR BY UNIT AND POP-UPS BY UNIT. ALARM FILTERS WERE ALREADY SET UP FOR RED ALARMS ONLY. THE RCE SAVED THE CONFIGURATION, AND TESTED RED ALARMS WITH THE CUSTOMER, AND THE AND POP-UPS WORKING. THERE WAS NO MALFUNCTION OF THE DEVICE, THIS WAS A CONFIGURATION ISSUE. THE DEVICE REMAINS AT THE CUSTOMER SITE, AND THERE HAVE BEEN NO SUBSEQUENT CALLS LOGGED FOR THIS DEVICE/ISSUE. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ALARM DID NOT TRIGGER ON A PATIENT WITH BRADYCARDIA, AS THE CHICKLETS (POP-UPS) WERE NOT ADDED ON TOP OF MONITOR SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730175 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening