BEUDAMED
    FDA Adverse Event Other Summary report: N

    IE33 ULTRASOUND SYSTEM

    MDR report key: 3805834 · Received April 29, 2014

    Report

    Report Number
    3019216-2014-00009
    Event Type
    Other
    Date Received
    April 29, 2014
    Report Date
    April 8, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K030455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE ENGINEER PERFORMED SYSTEM LEAKAGE AND PERFORMANCE TESTING WITH IN-HOUSE TECHNICIANS AND ALL VALUES WERE WITHIN THE NORMAL RANGES. THE SYSTEM WAS WORKING AS DESIGNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ELECTRIC SHOCK WHEN UNPLUGGING THE SYSTEM AND SUFFERED MINOR INJURY. THE CUSTOMER WAS CLINICALLY EVALUATED AND RETURNED TO WORK THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256605 IE33 ULTRASOUND SYSTEM IYO IYN ITX IYO PHILIPS ULTRASOUND, INC. 795052

    Patients

    Seq Age Sex Outcome Treatment
    1