BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ/W - 795202

    MDR report key: 3532818 · Received October 30, 2013

    Report

    Report Number
    3019216-2013-00013
    Event Type
    Malfunction
    Date Received
    October 30, 2013
    Report Date
    September 27, 2013
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ISSUE HAS BEEN INVESTIGATED FOR OTHER COMPLAINTS AND THE CAUSE IDENTIFIED AS FOLLOW; UNDER SYSTEM SETTINGS, IF THE SYSTEM DATE FORMAT IS SET TO INTERNATIONAL, "DD MM YYYY", THE SYSTEM CONTINUES TO INTERPRET THE DATE IS MM DD YYYY ON THE PATIENT DATA ENTRY (PDE) SCREEN. AS A RESULT, INPUT OF LAST MENSTRUAL PERIOD (LMP) IS DATE FORMATTED AS "MM DD YYYY" ON THE PDE SCREEN. A SYSTEM MISINTERPRETATION OF THE DATE IN THE LMP FIELD CAN CAUSE CALCULATION ERRORS IN GESTATIONAL AGE (GA) AND ESTABLISHED DUE DATE (EDD). THERE HAS BEEN NO REPORTED INJURY OR MISDIAGNOSIS. A HEALTH HAZARD EVALUATION WAS CONDUCTED OCTOBER 3, 2013, AND UPON FURTHER INVESTIGATION IT WAS DETERMINED THAT THE ISSUE COULD POTENTIALLY LEAD TO A CLINICIAN PRESCRIBING AN UNNECESSARY INVASIVE EXAM. A FCO WAS INITIATED ON (B)(4), 2013. THIS ISSUE HAS BEEN REPORTED TO APPROPRIATE REGULATORY AUTHORITIES. (B)(4).

    Description of Event or Problem · 1

    REPORT FROM CUSTOMER IN (B)(6) THAT THE INPUT FIELD FOR DATE OF LAST MENSTRUAL PERIOD (LMP) IS SET TO MM DD YY. IN (B)(6) CUSTOMERS REQUIRE A DATE FORMAT OF DD MM YY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558565 EPIQ/W - 795202 IYO, IYN, ITX IYO PHILIPS ULTRASOUND, INC. EPIQ 7W - 795202 US513B0387

    Patients

    Seq Age Sex Outcome Treatment
    1