BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 7903087 · Received September 24, 2018

    Report

    Report Number
    1218950-2018-07581
    Event Type
    Death
    Date Received
    September 24, 2018
    Report Date
    September 17, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838048645
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. PATIENT INFORMATION HAS BEEN REQUESTED, NOT AVAILABLE AT TIME OF REPORT. DATE OF EVENT HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    PHILIPS CANNOT RULE OUT A MALFUNCTION OF THE DEVICE. A PHILIPS RESPONSE CENTER ENGINEER (RCE) SPOKE TO THE CUSTOMER, AND CONFIRMED THAT THE PATIENT DIED AND THERE WAS NO PATIENT DATA ON THE CENTRAL STATION (PIC IX). A PHILIPS RESPONSE CENTER ENGINEER (RCE), AND ALSO A PHILIPS COMPLAINT INVESTIGATOR, ATTEMPTED TO OBTAIN FURTHER INFORMATION ON THIS CASE, HOWEVER, NO FURTHER RESPONSE WAS RECEIVED. NO PARTS HAVE BEEN ORDERED AND NO REPAIR WAS FOUND TO BE INITIATED. WE WILL CONSIDER THAT THE DEVICE REMAINS IN USE AT THE CUSTOMER SITE, AS NO SUBSEQUENT CALLS HAVE BEEN LOGGED FROM THIS CUSTOMER FOR THIS DEVICE/ISSUE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE REOPENED FOR AN INVESTIGATION. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NIGHT OF (B)(6) 2018 TO MORNING OF (B)(6) 2018, A SPO2 ALARM WAS NOT TRIGGERED FOR THE PATIENT IN ROOM USC12. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744582 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 Death