BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITI 70

    MDR report key: 11182391 · Received January 15, 2021

    Report

    Report Number
    3019216-2021-00012
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 17, 2020
    Product Code
    IYN
    UDI-DI
    00884838056251
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A THOROUGH INVESTIGATION WAS PERFORMED BY PRODUCT ENGINEERING TO ASSESS THE REPORTED ISSUE. A SERIES OF VALIDATION TESTS CONFIRMED THAT THE MEAN VELOCITY MEASUREMENTS WERE WITHIN SPECIFICATIONS AND PW MODE WAS WORKING AS INTENDED. THE SYSTEM WAS DETERMINED TO BE OPERATING AS DESIGNED. ADDITIONAL SETTINGS RECOMMENDATIONS WERE ALSO PROVIDED TO THE CUSTOMER TO HELP ACHIEVE THEIR PREFERRED WORKFLOW.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED ENCOUNTERING A DISCREPANCY WITH MCA DOPPLER VELOCITIES ON THEIR AFFINITI ULTRASOUND SYSTEM. THE MCA DOPPLER VELOCITY ON THEIR AFFINITI SYSTEM APPEARS TO BE HIGHER THAN THOSE ON A COMPETITOR¿S SYSTEMS. THESE VALUES ARE USED TO EVALUATE FETAL ANEMIA. IF THIS IS EXPECTED FROM THE MEASUREMENTS, A PERCUTANEOUS UMBILICAL BLOOD SAMPLING (PUBS) IS PERFORMED TO EXAMINE BLOOD FROM THE FETAL UMBILICAL CORD TO DETECT FETAL ANOMALIES. THE CUSTOMER HAS FOUND INSTANCES WHERE A PUBS WAS PERFORMED USING VALUES FROM THE AFFINITI WHERE THERE WAS NO EVIDENCE OF FETAL ANEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74555 AFFINITI 70 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN AFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEM 00884838056251

    Patients

    Seq Age Sex Outcome Treatment
    1