BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON SEQUOIA C512 CARDIOLOGY

    MDR report key: 1221424 · Received October 29, 2008

    Report

    Report Number
    1221424
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 29, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TEE WAS IN PROGRESS FOR APPROX. 12 MINUTES. PATIENT WAS SEDATED. SCREEN WENT BLACK WITH POP-UP MESSAGE STATING HARDWARE PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUSON SEQUOIA C512 CARDIOLOGY PROBE, ULTRASOUND, TRANSESPHAGEAL ECHO IYO SIEMENS MEDICAL SOLUTIONS USA, INC. 8264577 *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR