BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 9664204 · Received February 4, 2020

    Report

    Report Number
    1218950-2020-00804
    Event Type
    Death
    Date Received
    February 4, 2020
    Date of Event
    January 29, 2020
    Report Date
    January 30, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838086715
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY. THE FSE OBTAINED THE ALARM LOGS WHICH INDICATE THE ALARMS OCCURRED AT THE PIIC, AS EXPECTED. THE PAM ALARM WAS PAUSED AT 1054 HOURS. THE ALARM PAUSE INHIBITS ALL ALARMS FOR A GIVEN PERIOD, HERE, 3 MINUTES. THIS IS THE REASON WHY A NEW PAM ALARM WAS GENERATED AGAIN AT 1057 HOURS, WHICH WAS THEN SILENCED AT THE BEDSIDE MONITOR. AFTER A REVIEW OF THE ALARM LOG BY THE FSE AND PHILIPS REMOTE SUPPORT ENGINEER (RSE), IT WAS DETERMINED THAT THERE WAS NO INDICATION THAT THE PIIC MALFUNCTIONED. THIS INFORMATION WAS PROVIDED TO THE CUSTOMER VIA EMAIL. NO SUBSEQUENT CALLS WERE NOTED. THE DEVICE REMAINS IN USE AT THE CUSTOMER SITE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    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 A FAILURE TO ALARM FOR ASYSTOLE AND PAM ALARMS ON THEIR PHILIPS INTELLIVUE INFORMATION CENTER (PIIC). IT WAS FURTHER REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2020 AT APPROXIMATELY 1100 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130823 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389 00884838086715

    Patients

    Seq Age Sex Outcome Treatment
    1 Death