BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IE33 XMATRIX

    MDR report key: 5034303 · Received August 27, 2015

    Report

    Report Number
    5034303
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    July 16, 2015
    Report Date
    August 18, 2015
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE WERE SCANNING THE PATIENT FOR THEIR ECHO AND SWITCHED PROBES TO THE PEDS PROBE. THE PATIENT JUMPED, HE SAID THAT HE WAS BURNED. I SPOKE WITH THE PATIENT AFTER AND HE SAID IT FELT LIKE A SHOCKING SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567567 IE33 XMATRIX SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC. IE33

    Patients

    Seq Age Sex Outcome Treatment
    1 Other