BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSD-1400

    MDR report key: 349764 · Received August 23, 2001

    Report

    Report Number
    1222669-2001-00001
    Event Type
    Malfunction
    Date Received
    August 23, 2001
    Date of Event
    July 24, 2001
    Report Date
    August 21, 2001
    Manufacturer
    ALOKA CO., LTD.
    Product Code
    IYO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS RPEORTED THAT THE SYSTEM ALLEGEDLY MAKES A SIZZING SOUND AND EMITS BURNING ODOR WHEN POWERED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38475 SSD-1400 DIAGNOSTIC ULTRASOUND IYO ALOKA CO., LTD. SSD-1400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA