BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 6015090 · Received October 10, 2016

    Report

    Report Number
    1218950-2016-06404
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Report Date
    September 26, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS SENT IN ERROR AS A 5-DAY REPORT. WE ARE CANCELLING THIS EMDR REPORT AND CORRECTLY SUBMITTING THIS INCIDENT VIA EMDR #1218950-2016-5955087 WITH CORRECT DATA. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER SENT IN THEIR MX40 DEVICE FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666849 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1