BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIETTA 60 AND ARIETTA 70

    MDR report key: 4317222 · Received October 28, 2014

    Report

    Report Number
    9610865-2014-00002
    Event Type
    Malfunction
    Date Received
    October 28, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 28, 2014
    Manufacturer
    HITACHI ALOKA MEDICAL, LTD.
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SOFTWARE ERROR - INCORRECT DISPLAY OF THE GRID ADDRESS OF THE BRACHYTHERAPY TEMPLATE WHEN USING BI-PLANE TRANS-RECTAL PROBE C41L47RP WITH THE ARIETTA 60 & 70 DIAGNOSTIC ULTRASOUND SYSTEM. THE GRID ADDRESS (A THROUGH M) IS INVERTED HORIZONTALLY, DUE TO A SOFTWARE ERROR. THE PHENOMENON OCCURS WHEN CONNECTING PROBE MODEL# C41647RP AND BRACHYTHERAPY IS ACTIVATED. RISK ASSESSMENT OF HEALTH HAZARD: DURING THERAPEUTIC PLANNING, THERE IS POTENTIAL OF INSERTION OF RADIATION SEEDS IN AN INCORRECT LOCATION WITHIN BODY. SOLUTION: UPDATE THE SOFTWARE WITH SERVICE PACK SP-AR-60-S123-USA AND SP-AR-70-S123-USA. THESE TWO SERVICE PACKS WILL UPDATE SOFTWARE AND CORRECT THE ISSUE. INVESTIGATION: REVIEW OF ALL AFFECTED SERIAL NUMBERS SOLD WITHIN THE US FOR SERVICE AND COMPLAINT DID NOT IDENTIFY ANY CUSTOMER COMPLAINT OR ISSUE AT THIS TIME. REVIEW OF ALL SALES IDENTIFIED ONE CUSTOMER WITH THE ARIETTA 70 SYSTEM AND C41L47RP PROBE COMBINATION. NOTIFICATION WAS IMMEDIATELY SENT AND INVESTIGATION INDICATED THAT NO PATIENT WAS AFFECTED BY ISSUE. TO DATE, THE FEATURE COMBINATION HAS NOT BEEN UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690290 ARIETTA 60 AND ARIETTA 70 ARIETTA 60 AND ARIETTA 70 IYN HITACHI ALOKA MEDICAL, LTD. ARIETTA 60

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention