BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USYSTEMS INVENIA GEN 2

    MDR report key: 5464394 · Received February 26, 2016

    Report

    Report Number
    2954903-2016-00001
    Event Type
    Malfunction
    Date Received
    February 26, 2016
    Date of Event
    January 19, 2016
    Report Date
    February 26, 2016
    Manufacturer
    HCS SUNNYVALE
    Product Code
    PAA
    PMA / PMN Number
    PMA 110006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PRIMARY LESION MARKER FOR A BREAST ULTRASOUND SCAN ALLEGEDLY MOVED POSTERIOR UNEXPECTEDLY ON A SUBSEQUENT READING OF THE STUDY. IN THIS PARTICULAR CASE, THE READING PHYSICIAN WAS THE SAME PHYSICIAN WHO PERFORMED THE STUDY AND THEREFORE THE ISSUE WAS OBVIOUS TO THE USER. IT IS UNKNOWN WHETHER OR NOT THE READING DEVICE WAS MANUFACTURED BY GE HEALTHCARE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120888 USYSTEMS INVENIA GEN 2 AUTOMATED BREAST ULTRASOUND PAA HCS SUNNYVALE

    Patients

    Seq Age Sex Outcome Treatment
    1