BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITI 70 - 795210

    MDR report key: 9492206 · Received December 19, 2019

    Report

    Report Number
    3019216-2019-00092
    Event Type
    Malfunction
    Date Received
    December 19, 2019
    Report Date
    December 12, 2019
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838056251
    PMA / PMN Number
    K160807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A PHILIPS FIELD SERVICE ENGINEER INSPECTED THE SUSPECT ULTRASOUND SYSTEM AT THE CUSTOMER SITE. EXAMINATION OF THE SYSTEM LOGS REVEALED CORRUPT DATA WITHIN THE SYSTEM SOFTWARE. UPGRADING THE ULTRASOUND SYSTEM TO THE LATEST SOFTWARE VERSION RESOLVED THIS ISSUE AND THE SYSTEM WAS RETURNED TO CLINICAL USE WITH NO ADDITIONAL ISSUES REPORTED POST SOFTWARE UPGRADE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN AFFINITI 70 ULTRASOUND SYSTEM CRASHED DURING A DIAGNOSTIC SCAN PRIOR TO A CARDIAC PROCEDURE. ANOTHER ULTRASOUND WAS USED FOR DIAGNOSTIC SCANNING AND THE IMAGING LIMITATION DID NOT AFFECT CLINICAL JUDGMENT OR PATIENT OUTCOME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294676 AFFINITI 70 - 795210 SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 989605416151 US719F1762 00884838056251

    Patients

    Seq Age Sex Outcome Treatment
    1