BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MX800 PATIENT MONITOR

    MDR report key: 20108258 · Received August 30, 2024

    Report

    Report Number
    9610816-2024-00562
    Event Type
    Death
    Date Received
    August 30, 2024
    Date of Event
    August 5, 2024
    Report Date
    August 30, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    DSI
    PMA / PMN Number
    K150310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHILIPS REMOTE CLINICAL SUPPORT (RCS) CONTACTED THE CUSTOMER. IT WAS INDICATED THE X3 WAS DOCKED WITH THE MX800 HOST MONITOR, WHICH WAS NETWORKED WITH THE PIC IX. BOTH MONITORS WERE TESTED BY THE HOSPITAL AND FOUND TO BE WORKING AS EXPECTED. A REVIEW OF THE CLINICAL AUDIT LOGS REVEALED ALARMS WERE GENERATED OVER THE COURSE OF THE 5 HOUR EVENT TIMEFRAME; HOWEVER, THE USER DID NOT ACKNOWLEDGE OR PAUSE ALARMS DURING THAT TIME. THE CUSTOMER INDICATED THERE WAS NEVER ANY ALLEGATION OF DEVICE MALFUNCTION AND THE LOGS WERE REQUESTED DUE TO AN INTERNAL NURSING INVESTIGATION ONLY. THERE WAS NO DELAY IN CARE, THOUGH THE PATIENT WENT TO ICU AND LATER PASSED AWAY. AS THERE WAS NO MALFUNCTION AND NO DELAY IN CARE, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED PATIENT DEATH; HOWEVER, THE CAUSE REMAINS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CUSTOMER REQUESTED ASSISTANCE IN REVIEWING THE CLINICAL AUDIT LOGS AFTER A PATIENT PASSED AWAY. THE NURSE INDICATED THEY DID NOT HEAR AN ALARM AND THE UNIT MANAGER WAS TRYING TO DETERMINE IF ALARMS WERE ACKNOWLEDGED OR PAUSED AT THE TIME OF THE PATIENT INCIDENT. IT WAS INDICATED THERE WAS NO DELAY AND THE CUSTOMER SIMPLY WANTED TO RESEARCH ALARMS AS THE CUSTOMER WAS INVESTIGATING A STAFF ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096111 INTELLIVUE MX800 PATIENT MONITOR INTELLIVUE MX800 PATIENT MONITOR DSI PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 865240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death