BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX40 802.11A/B/G

    MDR report key: 11876535 · Received May 25, 2021

    Report

    Report Number
    1218950-2021-10593
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    May 17, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    DSI
    UDI-DI
    00884838030350
    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 EVALUATION AT BENCH REPAIR, IT WAS IDENTIFIED THAT THE DEVICE HAD NO AUDIO. 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
    777499 INTELLIVUE MX40 802.11A/B/G INTELLIVUE MX40 802.11A/B/G DSI PHILIPS NORTH AMERICA LLC 865352 00884838030350

    Patients

    Seq Age Sex Outcome Treatment
    1