BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 11626757 · Received April 7, 2021

    Report

    Report Number
    1218950-2021-10327
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 25, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    DSI
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE TECHNICIAN FOUND THERE WAS NO AUDIO DUE TO CORROSION ON THE SYSTEM BOARD SPEAKER CONNECTOR. 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 THE REPAIR BENCH THE SPEAKER AND SYSTEM BOARD WERE REPLACED AND THE DEVICE WAS UPDATED TO THE LATEST MANUFACTURING PROCESS, WITH ALL TESTING PASSING PER SPECIFICATIONS. THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 0

    THE HOSPITAL'S BIOMED REPORTED THE MX40 TELEMETRY DEVICE HAD NO SOUND. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF EVENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE HOSPITAL'S BIOMED REPORTED THE MX40 TELEMETRY DEVICE HAD NO SOUND. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523866 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS NORTH AMERICA LLC 865350 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1