BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 10128638 · Received June 8, 2020

    Report

    Report Number
    1218950-2020-03314
    Event Type
    Death
    Date Received
    June 8, 2020
    Date of Event
    May 21, 2020
    Report Date
    May 21, 2020
    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
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS RESPONSE CENTER ENGINEER (RCE) SPOKE TO THE CUSTOMER BIOMEDICAL ENGINEER (BIOMED). THE BIOMED SENT A COPY OF THE PHILIPS INFORMATION CENTER IX (PIC IX) ALARM AUDIT LOG. THE RCE REVIEWED THE INFORMATION, AND RESPONDED TO THE BIOMED. THE RCE INDICATED THAT FOR ROOM 7GN456, NOT KNOWING ANY DETAILS OF TIME AND WHAT OCCURRED, ALL THE RCE COULD SEE FROM THE AUDIT IS THAT THERE WERE MULTIPLE YELLOW ALARMS WITH SOUND FOR RR (RESPIRATIONS) SHOWING LOWER THAN ALARM LIMIT SET OCCURRING ON PICIX MIL7GN_SURV01, ALONG WITH SOME YELLOW ALARMS FOR NON-SUSTAINED VTACH, RUN PVC¿S AND ONE RED ALARM FOR VTACH. A PHILIPS COMPLAINT INVESTIGATOR (CI) ALSO REVIEWED THE PROVIDED LOG EXCERPT, AND SAW TWO INSTANCES OF SILENCING IN THE ALARM AUDIT LOG. FURTHER INFORMATION WAS REQUESTED BY THE COMPLAINT INVESTIGATOR, HOWEVER, NO RESPONSE WAS RECEIVED FROM THE BIOMED. BASED ON THE AVAILABLE INFORMATION, THERE WAS NO PRODUCT MALFUNCTION; THIS IS A USER ISSUE. THE REQUESTED REVIEW OF THE PROVIDED ALARM AUDIT LOG FOUND MULTIPLE ALARMS, ALONG WITH SILENCING BY THE USERS. THIS INFORMATION WAS PROVIDED TO THE BIOMED. THE DEVICE REMAINS AT THE CUSTOMER SITE. NO SUBSEQUENT CALLS HAVE BEEN LOGGED FOR THIS DEVICE/ISSUE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED ASSISTANCE WITH AN AUDIT LOG PULL REPORTING THAT A PATIENT DEATH HAD OCCURRED ON (B)(6) 2020 IN BED (B)(6). THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594637 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 Death