BEUDAMED
    FDA Adverse Event Death Summary report: N

    GE 6T MULTIPLANE ADULT TE PROBE

    MDR report key: 790187 · Received December 5, 2006

    Report

    Report Number
    9610482-2006-00001
    Event Type
    Death
    Date Received
    December 5, 2006
    Date of Event
    September 26, 2006
    Report Date
    December 5, 2006
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    ITX
    PMA / PMN Number
    K041552
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: SUBJECT DEVICE WAS EVALUATION BY THE MFR AND DETERMINED TO BE WITHIN MECHANICAL SPECIFICATIONS. OUTER COVERING OF THE PROBE WAS DAMAGED FROM BITE MARKS CAUSING IT TO FAIL ELECTRICAL LEAKAGE SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT A PT'S ESOPHAGUS WAS RUPTURED DURING A TE EXAM (TRANSESOPHAGEAL ECHOCARDIOGRAPHY). THE PT LATER DEVELOPED AN INFLAMMATION OF THE MEDIASTINUM (MEDIASTINITIS) AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE 6T MULTIPLANE ADULT TE PROBE TRANSESOPHAGEAL ECHOCARDIOGRAPHY PROBE ITX GE VINGMED ULTRASOUND AS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death