BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IE 33

    MDR report key: 4924405 · Received July 9, 2015

    Report

    Report Number
    4924405
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    March 26, 2015
    Report Date
    July 9, 2015
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    PATIENT BROUGHT BACK FOR ECHO DUE TO POSSIBLE MASS IN THE ATRIUM. DURING THE PROCEDURE, THE DEVICE WOULD NOT FUNCTION IN 3D, WHICH PREVENTED THE PHYSICIAN FROM SEEING THE LOCATION OF THE MASS WITHIN THE ATRIUM. THE MALFUNCTION DID NOT IMPACT THE PATIENT'S COURSE OF TREATMENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447814 IE 33 SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO PHILIPS ULTRASOUND, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR