BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 11611913 · Received April 4, 2021

    Report

    Report Number
    1218950-2021-10280
    Event Type
    Malfunction
    Date Received
    April 4, 2021
    Date of Event
    March 10, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION, THE BENCH REPAIR TECHNICIAN FOUND NO AUDIO/NO SOUND ON THE MX40 TELEMETRY DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509301 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