BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFINITI 70

    MDR report key: 19277778 · Received May 9, 2024

    Report

    Report Number
    3019216-2024-00066
    Event Type
    Injury
    Date Received
    May 9, 2024
    Date of Event
    May 2, 2024
    Report Date
    October 4, 2024
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838056251
    PMA / PMN Number
    K132304
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A THOROUGH INVESTIGATION TO DETERMINE THE REPORTED FAILURE WAS PERFORMED. THE CUSTOMER¿S SYSTEM SOFTWARE HAD BEEN AT REVISION 6.0.X AND WAS UPDATED TO REVISION 9.0.X. THE CUSTOMER¿S PERCEPTION AFTER THE UPDATE WAS THERE WAS COLOR DEGRADATION. THE INVESTIGATION FOUND THE REPORTED ISSUE WAS NOT REPRODUCED AND NO COLOR DEGRADATION WAS CONFIRMED. THE SYSTEM HAS RETURNED TO SERVICE WITH NO SIMILAR ISSUES REPORTED.

    Description of Event or Problem · 0

    A MISDIAGNOSIS WAS REPORTED WHEN USING THE AFFINITI 70 ULTRASOUND SYSTEM AND AN X5-1 TRANSDUCER. THE SYSTEM DID NOT PRODUCE QUALITY COLOR AND SPECTRAL DOPPLER SIGNAL WHEN PERFORMING A CARDIAC ULTRASOUND. A PATIENT HAD A PRIOR ECHO IN WHICH THE AORTIC STENOSIS GRADIENT WAS FOUND TO BE MODERATE-SEVERE INSTEAD OF MILD-MODERATE. THE MILD REGURGITANT JET WAS NEARLY IMPOSSIBLE TO SEE. THE PATIENT'S OUTCOME WAS AFFECTED DUE TO A CHANGE OF MEDICATION AND FURTHER TESTING TO CLASSIFY THE SEVERITY OF THE AORTIC STENOSIS. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490309 AFFINITI 70 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 00884838056251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other