BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOUCH ULTRASOUND

    MDR report key: 6067035 · Received October 31, 2016

    Report

    Report Number
    1317307-2016-00009
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    October 13, 2016
    Report Date
    November 30, 2016
    Manufacturer
    CARSTREAM HEALTH INC
    Product Code
    IYN
    PMA / PMN Number
    K152467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARESTREAM HEALTH HAS INVESTIGATED THIS ADVERSE EVENT AND HAS DETERMINED THIS IS A SOFTWARE DEFECT WHICH REQUIRES A CORRECTION TO THE INSTALLED BASE. A REPORT OF CORRECTIONS AND REMOVALS WAS SUBMITTED TO THE FDA ON NOVEMBER 15, 2016. THIS CONCLUDES THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    CARESTREAM HEALTH IS INVESTIGATING THIS COMPLAINT AND WILL PROVIDE A FOLLOW UP REPORT WITHIN THE REQUIRED TIMEFRAME. A CAPA HAS BEEN INITIATED TO DOCUMENT THIS INVESTIGATION AND ROOT CAUSE ANALYSIS.

    Description of Event or Problem · 1

    CARESTREAM HEALTH BECAME AWARE OF A SOFTWARE DEFECT WITH THE PRODUCT RESULTING FROM A CUSTOMER COMPLAINT. THIS DEFECT COULD RESULT IN INCORRECT MEASUREMENT UNITS.

    Description of Event or Problem · 1

    CARESTREAM HEALTH BECAME AWARE OF A SOFTWARE DEFECT WITH THE PRODUCT RESULTING FROM A CUSTOMER COMPLAINT. THIS DEFECT COULD RESULT IN INCORRECT MEASUREMENT UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717737 TOUCH ULTRASOUND TOUCH ULTRASOUND IYN CARSTREAM HEALTH INC

    Patients

    Seq Age Sex Outcome Treatment
    1