BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVENIA

    MDR report key: 5477703 · Received March 3, 2016

    Report

    Report Number
    2954903-2016-00002
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Date of Event
    February 3, 2016
    Report Date
    March 3, 2016
    Manufacturer
    U-SYSTEMS INC
    Product Code
    PAA
    PMA / PMN Number
    PMA 110006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED 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
    133722 INVENIA AUTOMATED BREAST ULTRASOUND PAA U-SYSTEMS INC USYS2A

    Patients

    Seq Age Sex Outcome Treatment
    1