BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDI 1000

    MDR report key: 112205 · Received August 12, 1997

    Report

    Report Number
    3019216-1997-00001
    Event Type
    Malfunction
    Date Received
    August 12, 1997
    Date of Event
    August 5, 1997
    Report Date
    August 12, 1997
    Manufacturer
    ADVANCED TECHNOLOGY LABORATORIES, INC.
    Product Code
    IYO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DISPLAY ERROR IN THE HDI 1000 ULTRASOUND SYS WAS DISCOVERED DURING RANDOM PRODUCTION TESTING BY ATL'S MFG QUALITY CONTROL GROUP. MOVING BETWEEN CERTAIN UNIQUE COMMAND SEQUENCES IN THE HDI 1000'S DUAL IMAGE DISPLAY AND IMAGE SAVE/RECALL FUNCTIONS RESULT IN A MONITOR DISPLAY WITH A MISMATCHED ULTRASOUND IMAGE AND OVERLAY GRAPHICS FOR SAVED IMAGES. THIS PROBLEM AFFECTS IMAGES STORED WITH THE SYS SAVE/RECALL FUNCTION. NO REPORTS OF THIS ERROR HAVE BEEN REC'D BY ATL FROM ANY OF ITS HDI 1000 CUSTOMERS. ON THE RECALLED FRAME, THE DEPTH POSITION AND SCALE MAY NOT MATCH THE ULTRASOUND IMAGE. MEASUREMENTS MADE ON AN IMAGE WITH THIS PROBLEM WILL BE IN ERROR. THE RANGE OF THE ERROR MAY BE FROM <1% TO THE MAXIMUM SYS ZOOM FACTOR OF 2.5 TIMES AND MAY CAUSE A POTENTIAL ERROR IN THE ASSESSMENT OF THE PT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM IYO ADVANCED TECHNOLOGY LABORATORIES, INC. 8500-0040-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other