BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 11811485 · Received May 12, 2021

    Report

    Report Number
    1218950-2021-10525
    Event Type
    Death
    Date Received
    May 12, 2021
    Date of Event
    April 16, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    DSI
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION INCLUDING PATIENT DEMOGRAPHICS AND CONFIRMATION OF OUTCOME, DEVICE IDENTIFIERS, LOG INFORMATION, AND INVESTIGATION RESULTS. NO ADDITIONAL INFORMATION WAS PROVIDED. THE CAUSE REMAINS UNKNOWN. THE DEVICE REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE TELEMETRY DEVICE WENT FROM OPERATIONAL TO NO SIGNAL STATE WITH NO ALERT. THE BIOMED FOUND THE DEVICE HAD A BROKEN CASE WHICH PREVENTED THE BATTERY FROM BEING SECURE. IT WAS REPORTED THE POTENTIAL SAFETY ISSUE OF THIS CASE IS RELATED TO A DEATH. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF EVENT. A PATIENT DEATH WAS REPORTED..

    Additional Manufacturer Narrative · 1

    (B)(4). A DEATH WAS REPORTED, BUT NOT OTHER INFORMATION WAS PROVIDED AT TIME OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TELEMETRY DEVICE WENT FROM OPERATIONAL TO NO SIGNAL STATE WITH NO ALERT. THE BIOMED FOUND THE DEVICE HAD A BROKEN CASE WHICH PREVENTED THE BATTERY FROM BEING SECURE. IT WAS REPORTED THE POTENTIAL SAFETY ISSUE OF THIS CASE IS RELATED TO A DEATH. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF EVENT. A PATIENT DEATH WAS REPORTED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711622 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS NORTH AMERICA LLC 865350 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1 Death