BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 11278202 · Received February 4, 2021

    Report

    Report Number
    1218950-2021-00774
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Report Date
    January 28, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE ACTUAL DEVICE WAS RETURNED TO PHILIPS WHERE THE TECHNICIAN WAS ABLE TO REPLICATE THE CUSTOMER'S ISSUE. THE TECHNICIAN FOUND THE AUDIO WORKED; HOWEVER, THE DEVICE HAD SPEAKER MALFUNCTION ALARM AND LOG MESSAGES. THERE WAS CORROSION ON THE SYSTEM BOARD NEAR THE SPEAKER CONNECTOR WHICH CAUSED INTERMITTENT AUDIO FAILURE. 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 THE MX40 HAD A SPEAKER MALFUNCTION BUT WAS UNABLE TO CONFIRM LOCAL AUDIO. 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
    180291 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1