BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 11859780 · Received May 20, 2021

    Report

    Report Number
    1218950-2021-10572
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    May 14, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    DSI
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE MX40 TELEMETRY DEVICE HAS A SPEAKER MALFUNCTION ERROR MESSAGE AND THE SPEAKER IS NOT WORKING. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MX40 TELEMETRY DEVICE HAS A SPEAKER MALFUNCTION ERROR MESSAGE AND THE SPEAKER IS NOT WORKING. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750626 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