BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOUCH ULTRASOUND

    MDR report key: 5720420 · Received June 13, 2016

    Report

    Report Number
    1317307-2016-00003
    Event Type
    Injury
    Date Received
    June 13, 2016
    Date of Event
    June 3, 2016
    Report Date
    July 11, 2016
    Manufacturer
    CARESTREAM HEALTH INC
    Product Code
    IYN
    PMA / PMN Number
    K152467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARESTREAM HEALTH INC., NOTIFIED SITES WITH IMPACTED DEVICES ON (B)(6 2016 AND THAT UNTIL A SOFTWARE CORRECTION IS MADE, CUSTOMER SITES SHOULD NOT USE THE 3 DISTANCE GENERIC VOLUME TOOL BUT INSTEAD USE THE TOOLBOX VOLUME CALCULATION FUNCTION, WHICH IS WORKING CORRECTLY,. A SOFTWARE UPDATE IS CURRENTLY BEING TESTED AND VALIDATED AND WILL BE DEPLOYED AS A CORRECTION TO THE FIELD WHEN READY. CARESTREAM HEALTH INC., WILL SUBMIT NOTICE OF A CORRECTION TO THE FDA AS SOON AS POSSIBLE, BUT CERTAINLY BEFORE (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    CARESTREAM HEALTH HAS INVESTIGATED THIS ADVERSE EVENT INCIDENT AND HAS DETERMINED THIS IS A SOFTWARE DEFECT WHICH REQUIRES A CORRECTION TO THE INSTALL BASE. A REPORT OF CORRECTIONS AND REMOVALS NOTIFICATION WAS SUBMITTED TO THE FDA ON JUNE 24, 2016.

    Description of Event or Problem · 1

    BASED ON FEEDBACK FROM PRODUCT DEMONSTRATIONS, CARESTREAM HEALTH INC HAS BEEN MADE AWARE OF A SOFTWARE DEFECT WITH INCORRECT VOLUME CALCULATION WHEN USING THE 3 DISTANCE GENERIC VOLUME TOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375827 TOUCH ULTRASOUND TOUCH ULTRASOUND IYN CARESTREAM HEALTH INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other