BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 11068619 · Received December 23, 2020

    Report

    Report Number
    1218950-2020-08054
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Report Date
    December 16, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE ACTUAL DEVICE WAS RETURNED TO PHILIPS BENCH WHERE THE TECHNICIAN FOUND THE AUDIO WORKED; HOWEVER, THE DEVICE HAD SPEAKER MALFUNCTION ALARM AND LOG MESSAGES DUE TO 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. 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 IS NOT GENERATING ANY SOUND BUT IS VIBRATING WHEN ALARMS ARE TO SOUND. 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
    1533980 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1