BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MX800 PATIENT MONITOR

    MDR report key: 6063214 · Received October 28, 2016

    Report

    Report Number
    9610816-2016-00289
    Event Type
    Death
    Date Received
    October 28, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 17, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE ISSUE IS NOT KNOWN. WE ARE CONSIDERING THAT THIS MAY HAVE BEEN A MALFUNCTION AT THE TIME OF THE EVENT SINCE PHILIPS WAS UNABLE TO OBTAIN ADEQUATE INFORMATION IN ORDER TO DEMONSTRATE NO MALFUNCTION OCCURRED AT THE TIME OF THE EVENT. CUSTOMER DID NOT PROVIDE ALL THE REQUESTED DETAILED INFORMATION DESPITE MULTIPLE ATTEMPTS. LOG FILES WERE COLLECTED AND REVIEWED BUT WERE INCOMPLETE; IT COULD NOT BE DETERMINED WHAT ALARMS MAY HAVE BEEN PROVIDED AT THE TIME OF THE INCIDENT. THE BEDSIDE MONITOR AND THE CONNECTED CENTRAL STATION WERE TESTED POST INCIDENT BY THE SITE RESPONSIBLE FSE AND THE DEVICES ARE WORKING (AND ALARMING) AS SPECIFIED. BOTH THE CENTRAL STATION AND MONITOR ARE STILL IN USE AND WERE NEVER REMOVED FROM USE BY THE CUSTOMER. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT ON LVAD WENT INTO VTACH THEN VFIB. THE DEVICE ALARMED AND STAFF DEFIBRILLATED THE PATIENT AND THOUGHT THE PATIENT HAD RETURNED TO VTACH. FOUR HOURS LATER THERE WAS AN ALARM FOR LOW BP. THE CARDIOLOGIST SAID THE PATIENT'S RHYTHM WAS VFIB THE WHOLE TIME BUT SOME PERFUSION DUE TO LVAD BUT NOT ENOUGH - ORGAN FAILURE OCCURRED. PATIENT MADE DNR AND DIED. CARDIOLOGIST DIDN'T UNDERSTAND WHY THE MONITOR DID NOT ALARM FOR ON GOING VFIB.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE CUSTOMER HAD A PATIENT ON LVAD (LEFT VENTRICULAR ASSIST DEVICE) WHO WENT INTO VTACH THEN VFIB. THE ALARM SOUNDED, STAFF DEFIBRILLATED THE PATIENT AND THOUGHT PATIENT HAD RETURNED TO VTACH. PATIENT WAS IN THIS RHYTHM 4 HOURS THEN THERE WAS AN ALARM FOR LOW BP. CARDIOLOGIST SAID RHYTHM WAS VFIB THE WHOLE TIME BUT SOME PERFUSION DID OCCUR DUE TO LVAD BUT NOT ENOUGH, THEN ORGAN FAILURE OCCURRED. PATIENT MADE DNR AND DIED. CARDIOLOGIST DIDN'T UNDERSTAND WHY THE MONITOR DID NOT ALARM FOR ON GOING VFIB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715114 INTELLIVUE MX800 PATIENT MONITOR INTELLIVUE MX800 PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS 865240 (MX800)

    Patients

    Seq Age Sex Outcome Treatment
    1