BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 8137463 · Received December 6, 2018

    Report

    Report Number
    1218950-2018-09447
    Event Type
    Death
    Date Received
    December 6, 2018
    Date of Event
    November 20, 2018
    Report Date
    November 20, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE LEADSET WAS OFF THE PATIENT AND SOME HOURS LATER THE PATIENT HAD A CARDIAC EVENT AND EXPIRED. THE CUSTOMER ALLEGED THAT THE ALARMS MAY NOT HAVE SOUNDED AND THE MX40 DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED A PATIENT DEATH. THE ADVERSE EVENT OCCURRED (B)(6) 2018 BETWEEN THE HOURS OF 2 AM AND 8 AM FOR BED LABEL 203, AND EQUIPMENT LABEL IMU04. PER THE MX40 TELEMETRY PRODUCT SUPPORT ENGINEER, THE MX40 REVIEW ALARMS LOG SHOWS THAT A ECG LEADS OFF INOP WAS PROVIDED AT 04:03 ON (B)(6) 2018, IMMEDIATELY FOLLOWED BY A LEADSET UNPLUGGED INOP. THIS IS CONSISTENT WITH DISCONNECTION OF THE LEAD SET FROM THE MX40 DEVICE. NOTE THAT UPON DISCONNECTION OF THE LEAD SET, THE DEVICE WILL INITIALLY RECOGNIZE LOSS OF ECG DATA AND PROVIDE AN ECG LEADS OFF INOP, WHICH IS THEN REPLACED BY THE LEADSET UNPLUGGED INOP (FOR LOSS OF COMMUNICATION WITH THE LEAD SET EEPROM). THE LOG ALSO SHOWS THAT THE INOP WAS SILENCED AT 04:08 ON (B)(6) 2018. THE MX40 WAS SENDING DATA TO THE PIIC AS SPECIFIED. AT 04:03 AM ON (B)(6) 2018, THE LEAD SET WAS DISCONNECTED FROM THE MX40, AND ECG LEADS OFF AND LEADSET UNPLUGGED INOPS WERE GENERATED AS APPROPRIATE AND AS DESIGNED. THE ECG LEADS OFF / LEADSET UNPLUGGED INOP WAS SILENCED AT THE PIIC, INDICATING THAT THE ALARM WAS PROVIDED, AND THEN RECOGNIZED AND RESPONDED TO BY STAFF. THE DEVICE WAS RETURNED TO THE FACTORY WHERE THE PRODUCT SUPPORT ENGINEER CONCLUDED THAT THERE WAS NO DATA TO SUPPORT A MALFUNCTION; THE DEVICE PERFORMED AS SPECIFIED. THE MX40 DEVICE WAS UPDATED TO THE LATEST HARDWARE AND SOFTWARE AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PATIENT DEATH. THE ADVERSE EVENT OCCURRED BETWEEN THE HOURS OF 2AM AND 8AM FOR BED LABEL (B)(6), AND EQUIPMENT LABEL (B)(6). THE DEVICE WAS IN USE MONITORING THE PATIENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977134 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death