BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ 5G - 795204

    MDR report key: 4596682 · Received March 12, 2015

    Report

    Report Number
    3019216-2015-00014
    Event Type
    Malfunction
    Date Received
    March 12, 2015
    Report Date
    February 12, 2015
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 ON (B)(6) 2015, WHICH CONCLUDED THE ISSUE COULD POTENTIALLY LEAD TO A CLINICIAN PRESCRIBING UNNECESSARY TREATMENT. THE ERROR HAS BEEN CORRECTED IN V1.3.3 SOFTWARE. ADDITIONAL CORRECTIVE ACTION INFORMATION WILL BE PROVIDED IN A FOLLOW-UP REPORT. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    PHILIPS HAS CORRECTED THE ISSUE IN VERSION 1.3.3 SOFTWARE. THIS ISSUE HAS BEEN REPORTED TO THE APPROPRIATE REGULATORY AUTHORITIES AND A FIELD CORRECTION (FCO79500336) WAS IMPLEMENTED ON (B)(6) 2015.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH PATIENT WEIGHT VALUES BEING RETRIEVED WITH A DIFFERENT VALUE FROM THE ORIGINAL VALUE ENTERED WHEN A NEW CARDIO STUDY IS APPENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH PATIENT WEIGHT VALUES BEING RETRIEVED WITH A DIFFERENT VALUE FROM THE ORIGINAL VALUE ENTERED WHEN A NEW CARDIO STUDY IS APPENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171100 EPIQ 5G - 795204 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22 IYN PHILIPS ULTRASOUND, INC EPIQ 5G - 795204 USD13C0195

    Patients

    Seq Age Sex Outcome Treatment
    1