BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX40 802.11A/B/G

    MDR report key: 11265089 · Received February 2, 2021

    Report

    Report Number
    1218950-2021-00689
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Report Date
    January 27, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE ACTUAL DEVICE WAS RETURNED TO PHILIPS BENCH WHERE THE TECHNICIAN WAS UNABLE TO REPLICATE THE CUSTOMER'S ALLEGATION OF NO SOUND. THE TECHNICIAN CONFIRMED THE DEVICE HAD SPEAKER MALFUNCTION ALARM AND LOG MESSAGES; HOWEVER, THE AUDIO WAS WORKING. THERE WAS CORROSION ON THE SYSTEM BOARD NEAR THE SPEAKER CONNECTOR, WHICH CAUSED THE SPEAKER ALARM MESSAGES. CORROSION IS KNOWN TO BE CAUSED BY IMPROPER CLEANING/DISINFECTION OF THE MX40/MX4J PMW AND/OR USE OF UNAPPROVED CLEANING AND DISINFECTING AGENTS. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPEAKER MALFUNCTION ERROR MESSAGE AND A LOSS OF AUDIO ON THE MX40 TELEMETRY DEVICE. IT WAS REPORTED THE DEVICE WAS NOT IN CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167417 INTELLIVUE MX40 802.11A/B/G PATIENT MONITOR DSI PHILIPS MEDICAL SYSTEMS 865352

    Patients

    Seq Age Sex Outcome Treatment
    1