BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLISPHERE EVENT MANAGEMENT

    MDR report key: 7425892 · Received April 12, 2018

    Report

    Report Number
    1218950-2018-03335
    Event Type
    Death
    Date Received
    April 12, 2018
    Date of Event
    March 9, 2018
    Report Date
    March 16, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MSX
    PMA / PMN Number
    K102974
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THERE IS NO DATA TO SUPPORT AN IEM (INTELLISPACE EVENT MANAGEMENT) MALFUNCTION. THE IEM MESSAGE LOG SHOWS THAT THE NICU FLOAT NURSE WAS SENT THE BRADY ALARM MESSAGE AT 03:19:15. BASED ON THE INFORMATION PROVIDED IT CAN NOT BE RULED OUT THAT THE IEM PAGING SYSTEM MAY HAVE BEEN A FACTOR IN THE ADVERSE EVENT ALTHOUGH THERE WAS NO ALLEGATION THAT ANY PHILIPS CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. THERE IS NO DATA TO SUPPORT A PHILIPS DEVICE MALFUNCTION ASSOCIATED WITH THE IEM PAGING SYSTEM ITSELF. THE IEM (INTELLISPACE EVENT MANAGEMENT) PAGING SYSTEM IS LABELED AS A MEANS OF ALARM INFORMATION NOTIFICATION. ISSUES WITH PAGING WOULD NOT PREVENT THE MONITORING DEVICE FROM CONTINUING TO PROVIDE REAL-TIME MONITORING AND ALARMS. THE SYSTEM IS NOT INTENDED TO PROVIDE REAL-TIME INFORMATION, NOR IS IT THE SOURCE OF ALARMS, NOR IS IT A REPLACEMENT FOR ALARMING DEVICES. THEREFORE THIS ISSUE WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE PAGING DEVICE IS USED PER PRODUCT LABELING.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED ASKING FOR PAGING LOG INFORMATION FROM (B)(6) 2018 BETWEEN 03:00 TO 03:45 TO SEE ALL ALARMS TO THE CISCO PHONES THAT WERE ASSIGNED TO ROOM 332 THAT WERE SENT BY THE EMERGIN PAGING SYSTEM. THERE WAS A PATIENT DEATH AND THE CUSTOMER WANTED TO DO FOLLOW-UP DATA COLLECTION. FURTHER INVESTIGATION IS REQUIRED TO UNDERSTAND IF THE PAGING SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269802 INTELLISPHERE EVENT MANAGEMENT COMMUNICATION SYSTEM MSX PHILIPS MEDICAL SYSTEMS 866030

    Patients

    Seq Age Sex Outcome Treatment
    1 Death