BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE VINGMED

    MDR report key: 1000363 · Received February 15, 2008

    Report

    Report Number
    MW5005580
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 15, 2008
    Manufacturer
    GE
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OUTPT HAVING TEE PERFORMED TO EVALUATE ECHODENSE MASS ON ANTERIOR LEAFLET OF MITRAL VALVE; TEE PROBE STOPPED WORKING 10 MINS AFTER START OF STUDY -WHILE IN PT'S ESOPHAGUS-. PROBE WAS CHECKED AND CALIBRATED PRIOR TO PROCEDURE; ATTEMPTS AT RECALIBRATING PROBE UNSUCCESSFUL. PROBE REMOVED AND PROCEDURE STOPPED UNTIL NEW PROBE OBTAINED WHICH RESULTED IN 10 MIN DELAY IN PROCEDURE BUT NO HARM TO PT, WHO WAS DISCHARGED LATER THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE VINGMED TRANSESOPHAGEAL ULTRASOUND PROBE IYO GE 62822

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR