BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6T-RS ULTRASOUND PROBE

    MDR report key: 1659320 · Received April 13, 2010

    Report

    Report Number
    9610482-2010-00002
    Event Type
    Malfunction
    Date Received
    April 13, 2010
    Date of Event
    March 13, 2010
    Report Date
    April 13, 2010
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K033139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AFTER USING A NEW 6T-RS TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) PROBE, THREE PTS PRESENTED BLACK SALIVA AND A BLACK TONGUE, AS WELL AS INFLAMMATION OF THE THROAT. THIS IS THE 2ND OF THREE REPORTS. THE CUSTOMER IS REPORTEDLY USING THE SAME PROCEDURES AND LIQUIDS FOR CLEANING AND DISINFECTING THE TEE PROBE AS THEY HAD PREVIOUSLY. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6T-RS ULTRASOUND PROBE TRANSESOPHAGEAL ULTRASOUND IYN GE VINGMED ULTRASOUND AS KN100093

    Patients

    Seq Age Sex Outcome Treatment
    1