BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USYSTEMS INVENIA GEN 2

    MDR report key: 7984662 · Received October 19, 2018

    Report

    Report Number
    3005860720-2018-00003
    Event Type
    Injury
    Date Received
    October 19, 2018
    Date of Event
    September 8, 2018
    Report Date
    December 19, 2018
    Manufacturer
    U-SYSTEMS, INC.
    Product Code
    PAA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FACILITY BELIEVES THE PATIENT WAS SCANNED WITH THE CORRECT COMPRESSION SETTINGS AND SCAN TECHNIQUES, AND THEY DO NOT BELIEVE THE PATIENT WAS IMPROPERLY SCANNED NOR DO THEY BELIEVE THE ULTRASOUND SCANNER (INVENIA ABUS) MALFUNCTIONED. AN INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    GE'S INVESTIGATION HAS FINISHED. A REVIEW OF THE SYSTEM HISTORY SHOWED NO OCCURRENCES OF THE SAME OR SIMILAR ISSUE, AND SERVICE ENGINEERING CONFIRMED THE SYSTEM WAS NOT MALFUNCTIONING. REVIEW OF OUR COMPLAINT FILE SHOWED NO OCCURRENCES OF THE SAME OR SIMILAR ISSUE. REVIEW OF TRAINING MATERIAL AND THE USER MANUAL SHOWED ADEQUATE INSTRUCTIONS AND CONFIRMED THERE ARE INSTRUCTIONS FOR HOW TO STOP THE EXAM IMMEDIATELY SHOULD THE PATIENT BECOME UNCOMFORTABLE. THE COMPRESSION ASSIST SETTING USED APPLIES NO MORE THAN 21LBS PRESSURE AND IT CANNOT BE DETERMINED HOW MUCH ADDITIONAL PRESSURE THE USER APPLIED. THE USER DID NOT STOP THE EXAM WHEN THE PATIENT INDICATED DISCOMFORT AS WOULD HAVE BEEN EXPECTED FROM A TRAINED USER, AND THERE ARE INDICATIONS THE USER, WHO WAS A TRAVELING TECHNICIAN, HAD NOT BEEN TRAINED TO USE THE SYSTEM. GE HAS REMINDED THE FACILITY OF THE RESPONSIBILITY FOR TRAINING IN ABUS USAGE. GE'S CONCLUSION IS THERE WAS NO SYSTEM MALFUNCTION AND NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING A BREAST SCAN THE PATIENT COMPLAINED OF RIB PAIN. THE SCAN WAS COMPLETED, AND THE PATIENT WAS SENT HOME. A COUPLE DAYS LATER THE PATIENT CALLED BACK STATING THE PAIN DID NOT SUBSIDE, SO SHE WENT TO HER PHYSICIAN WHO ORDERED AN XRAY, AND THE RADIOLOGY REPORT WAS SUPPLIED TO (B)(6) HOSPITAL. WITHIN THE RADIOLOGY REPORT IT WAS NOTED THAT RIBS 11&12 WERE DISPLACED, HOWEVER THEY COULD NOT CONFIRM THE DATE OF THE INJURY AND WHETHER THERE WAS A PRE-EXISTING RIB INJURY. THE PATIENT ALLEGES THE ULTRASOUND BREAST SCAN IS THE CAUSE OF HER BROKEN RIBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824066 USYSTEMS INVENIA GEN 2 AUTOMATED BREAST ULTRASOUND PAA U-SYSTEMS, INC. USYST2 INVS1700072

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other