BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON

    MDR report key: 364958 · Received December 4, 2001

    Report

    Report Number
    2936884-2001-00147
    Event Type
    Malfunction
    Date Received
    December 4, 2001
    Report Date
    December 4, 2001
    Manufacturer
    ACUSON CORP.
    Product Code
    IYO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT WHEN IMAGING IN 2D WITH CARDIOLOGY PROBES SET AT 4.0 MHZ AND ABOVE, AND SWITCHING TO AUX CW, THE DISPLAYED PEAK VELOCITY IS APPROX 20% LOWER THAN AN ACTUAL PHANTOM VALUE OF 1.88 M/SEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54386 ACUSON DIAGNOSTIC ULTRASOUND DEVICE IYO ACUSON CORP. XP128 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other