BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 7082082 · Received December 5, 2017

    Report

    Report Number
    1218950-2017-08128
    Event Type
    Death
    Date Received
    December 5, 2017
    Date of Event
    November 13, 2017
    Report Date
    November 15, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT WISH TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THIS CASE WHEN ADDITIONAL QUESTIONS WERE ASKED BY PHILIPS. PER COMMUNICATIONS WITH THE BIOMEDICAL ENGINEER, THE NURSING STAFF DID NOT RECORD OR REPORT AN INCIDENT WITH THE DEVICE CAUSING THE PATIENT EVENT. THE CUSTOMER ORIGINALLY REQUESTED ASSISTANCE FROM PHILIPS TO EXPORT THE CLINICAL LOG ON THE TELEMETRY DEVICE. ONCE THE CUSTOMER REALIZED THAT THE ISSUE WAS ON THE PIC (PATIENT INFORMATION CENTER) CLASSIC AND THEY COULD NOT EXPORT THE AUDIT LOG AS WITH THE PIC IX THEY DID NOT REQUEST A FULL INVESTIGATION AS AGAIN, THE CUSTOMER STATED IT WAS NOT REPORTED AS AN INCIDENT CAUSED BY A PHILIPS DEVICE, THEREFORE NO ADDITIONAL INFORMATION WAS REQUIRED BY PHILIPS. WE WILL NOT CONSIDER A PHILIPS DEVICE A FACTOR IN THE PATIENT DEATH.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ALARMS WERE NOT PROVIDED FOR A PATIENT MONITORED VIA AN MX40 TELEMETRY DEVICE AND THE PATIENT SUBSEQUENTLY DIED. SINCE THE DEVICE WAS IN USE AND STAFF WERE NOT AWARE OF THE PATIENT ALARMS, THE DEVICE MAY HAVE BEEN A FACTOR IN A DELAY OF RESPONSE TO THE PATIENT. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862968 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1 Death