BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ 7C-795201

    MDR report key: 3469866 · Received October 17, 2013

    Report

    Report Number
    3019216-2013-00011
    Event Type
    Malfunction
    Date Received
    October 17, 2013
    Report Date
    September 18, 2013
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ISSUE WAS DISCOVERED DURING INTERNAL TESTING. INITIAL INVESTIGATION OF THE ISSUE DETERMINED A SOFTWARE ANOMALY AS THE CAUSE OF THE ERROR. THERE HAS BEEN NO REPORTED INJURY OR MISDIAGNOSIS. A HEALTH HAZARD EVALUATION WAS CONDUCTED (B)(4) 2013, AND UPON FURTHER INVESTIGATION THIS ISSUE COULD POTENTIALLY LEAD TO A CLINICIAN PRESCRIBING AN UNNECESSARY INVASIVE EXAM.

    Description of Event or Problem · 1

    CHANGING THE SYSTEM DATE FORMAT IN SYSTEM SETTINGS DOES NOT PERSIST TO THE PATIENT DATA ENTRY (PDE) SCREEN. UNDER SYSTEM SETTINGS, WHEN CHANGING THE SYSTEM DATE FORMAT FROM MM/DD/YYYY TO DD/MM/YYYY, THE SYSTEM CONTINUES TO INTERPRET THE DATE AS MM/DD/YYYY ON THE PDE SCREEN. A SYSTEM MISINTERPRETATION OF THE DATE IN THE (LAST MENSTRUAL PERIOD) LMP FIELD CAN CAUSE CALCULATION ERRORS IN GESTATIONAL AGE (GA) AND ESTABLISHED DUE DATE (EDD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533703 EPIQ 7C-795201 IYN, ITX IYO PHILIPS ULTRASOUND, INC. EPIQ 7C-795201 US713B0192

    Patients

    Seq Age Sex Outcome Treatment
    1