BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 11371997 · Received February 24, 2021

    Report

    Report Number
    1218950-2021-00889
    Event Type
    Malfunction
    Date Received
    February 24, 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
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE ACTUAL DEVICE WAS RETURNED TO PHILIPS BENCH WHERE THE TECHNICIAN WAS ABLE TO REPLICATE THE CUSTOMER'S ISSUE. THE TECHNICIAN FOUND THE AUDIO WAS WORKING; HOWEVER, THE DEVICE HAD A SPEAKER MALFUNCTION ALARM AND LOG MESSAGES DUE TO DAMAGE AND CORROSION ON THE SYSTEM BOARD. CORROSION IS KNOWN TO BE CAUSED BY IMPROPER CLEANING/DISINFECTION OF THE MX40/MX4J PMW AND/OR USE OF UNAPPROVED CLEANING AND DISINFECTING AGENTS. AT BENCH REPAIR, THE SYSTEM BOARD WAS REPLACED AND THE DEVICE WAS UPDATED TO THE LATEST HARDWARE AND SOFTWARE PER ASSEMBLY PROCEDURES 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 REPORTS THAT THE MX40 HAS A SPEAKER MALFUNCTION. GOOD FAITH EFFORTS WERE MADE TO CONFIRM LOCAL AUDIO; HOWEVER NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273277 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1