BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP80 INTELLIVUE PATIENT MONITOR

    MDR report key: 6216407 · Received December 30, 2016

    Report

    Report Number
    9610816-2016-00344
    Event Type
    Death
    Date Received
    December 30, 2016
    Date of Event
    December 28, 2016
    Report Date
    December 29, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Additional Manufacturer Narrative · 1

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND PERFORMED OPERATING TESTS; NO PROBLEM WAS DETECTED. THE FIRST ANALYSIS OF THE ALARM LOGS BY PHILIPS TECHNICAL SUPPORT SHOWED A BRADYCARDIA VALIDATED ON THE CENTRAL STATION 1 MINUTE AFTER THE BEGINNING OF THE EVENT; AND ALARM REMINDER EVERY 3 MINUTES WAS WORKING. FURTHER REVIEW BY A PHILIPS CLINICIAN CONFIRMED MULTIPLE ALARMS AT THE CENTRAL STATION AROUND THE TIME OF THE REPORTED EVENT. THE CUSTOMER HAD REPORTED THAT THE INCIDENT OCCURRED ¿AROUND 5:30 PM¿ HOWEVER STORED PHYSIOLOGICAL DATA WAS PROVIDED AND REVIEWED WHICH INDICATED THAT THE PATIENT¿S HEART RATE DID NOT DROP BELOW 50 UNTIL 17:40. THE LOGS SUPPORT THAT A ***VENT TACH ALARM WAS PROVIDED AT 17:25 WHICH WAS SILENCED AT THE CENTRAL 10 MINUTES LATER; A ***BRADY ALARM WAS THEN PROVIDED AT 17:41 WHICH WAS SILENCED WITHIN ONE MINUTE. SUBSEQUENT ***VTACH, ***VENT FIB/TACH AND ***ASYSTOLE ALARMS WERE ALSO PROVIDED WITH EVIDENCE OF SILENCING OCCURRING AT THE CENTRAL. NO MALFUNCTION OF THE DEVICE WAS DETECTED BY A THE FSE. A PHILIPS CLINICIAN ALSO CONFIRMED MULTIPLE ALARMS HAD OCCURRED AND WERE TRANSMITTED FROM THE BEDSIDE TO THE CENTRAL STATION AROUND THE TIME OF THE REPORTED EVENT. THE DEVICE REMAINS AT THE CUSTOMER SITE. NO SUBSEQUENT CALLS HAVE BEEN LOGGED FOR THIS DEVICE/ISSUE. . NO FURTHER INVESTIGATION IS WARRANTED .

    Description of Event or Problem · 1

    THE USERS REPORTED THAT THERE WAS NO RINGING ON THE MONITOR AND CENTRAL STATION, OCCURRED DURING AN INCIDENT ON (B)(6) 2016 AT AROUND 5:30PM. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866057 MP80 INTELLIVUE PATIENT MONITOR COMPACT PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8008A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death