BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3155 UPGRADE REL N.01

    MDR report key: 11723117 · Received April 26, 2021

    Report

    Report Number
    1218950-2021-10420
    Event Type
    Death
    Date Received
    April 26, 2021
    Date of Event
    March 21, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A PHILIPS FIELD SERVICE ENGINEER WENT ONSITE TO PULL THE PATIENT LOGS FOR THE EVENT. A REVIEW OF THE LOGS INDICATE THAT THE LEADS OFF EVENT ALARMED AT THE CENTRAL STATION AND WAS SUBSEQUENTLY SILENCED WITHIN TWO SECONDS. SINCE THE LEADS OFF ALARM WAS SILENCED AT THE CENTRAL STATION A RESET MESSAGE WAS SENT THROUGH IEM. THIS MESSAGE INDICATES THAT THE CLINICAL TEAM AT THE CENTRAL HAD ACCEPTED, READ, AND CANCELED THE ALERT. THERE WAS NO MALFUNCTION OF THE PHILIPS DEVICE. THE AUDIT LOGS PROVE THAT THE SYSTEM WAS OPERATING CORRECTLY. THE CLINICAL STAFF AT THE CENTRAL STATION HAD SILENCED THE LEADS OFF ALERT WHICH IS WHY THE ALERT DID NOT GO THROUGH IEM. THE CUSTOMER WAS INFORMED ABOUT HOW THE ALARM SYSTEM WORKS. NO FURTHER INVESTIGATION IS WARRANTED. THE DEVICE REMAINS ON SITE AND IN USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY DID NOT RECEIVE AN ALERT IN THEIR INTELLISPACE EVENT MANAGEMENT (IEM) SYSTEM FOR A LEADS OFF EVENT THAT LED TO A PATIENT DEATH ON (B)(6) 2021 AT 2:42 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624550 M3155 UPGRADE REL N.01 M3155 UPGRADE REL N.01 MHX PHILIPS NORTH AMERICA LLC 866103

    Patients

    Seq Age Sex Outcome Treatment
    1 Death