BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSD-ALPHA10

    MDR report key: 2318698 · Received October 30, 2011

    Report

    Report Number
    2318698
    Event Type
    Malfunction
    Date Received
    October 30, 2011
    Date of Event
    September 14, 2011
    Report Date
    October 26, 2011
    Manufacturer
    HITACHI ALOKA MEDICAL, LTD. AMERICA OFFICE
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    MEDICAL ASSISTANT WENT TO MOVE ALOKA ULTRASOUND PROCESSOR FOR PROCEDURE. ATTACHED MONITOR SWUNG AROUND AND STRUCK HER IN RIGHT EYEBROW AREA. INITIAL REDNESS AND MILD SWELLING. WHEN LOOKING AT ALOKA DESIGN, THERE IS NO STOP TO PREVENT MONITOR FROM FREELY TURNING ON AXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SSD-ALPHA10 ULTRASOUND UNIT, DIAGNOSTIC IYN HITACHI ALOKA MEDICAL, LTD. AMERICA OFFICE SSDALPHA10 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *