BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 4925877 · Received July 20, 2015

    Report

    Report Number
    1218950-2015-03890
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Report Date
    July 9, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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 THAT THERE WAS NO AUDIBLE ALARM ON THEIR MX40 DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS NO AUDIBLE ALARM ON THEIR MX40 DEVICE. THERE WAS NO PATIENT HARM REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469785 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1