BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON

    MDR report key: 350524 · Received September 4, 2001

    Report

    Report Number
    2936884-2001-00031
    Event Type
    Malfunction
    Date Received
    September 4, 2001
    Date of Event
    January 20, 2000
    Report Date
    September 4, 2001
    Manufacturer
    ACUSON CORP.
    Product Code
    IYO
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DATE WRONG. SYSTEM DATE CHANGES AHEAD FROM 3-4 DAYS. THIS CAN IMPACT OB CALCULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39929 ACUSON DIAGNOSTIC ULTRASOUND DEVICE IYO ACUSON CORP. SEQUOIA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other