BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSESOPHAGEAL ENDOSCOPIC TRANSDUCER

    MDR report key: 1833893 · Received September 8, 2010

    Report

    Report Number
    3019216-2010-00006
    Event Type
    Other
    Date Received
    September 8, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 27, 2010
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    ITX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMED AT THE USER FACILITY DETERMINED THE IE33 AND TRANSDUCER WERE PERFORMING AS INTENDED. THE CAUSE OF THE INJURY IS UNKNOWN AND THERE HAVE BEEN NO CONFIRMED MALFUNCTION OF THE DEVICES INVOLVED IN THIS CASE.

    Description of Event or Problem · 1

    AN ADVERSE EVENT WAS REPORTED TO PHILIPS MEDICAL SYSTEMS BY (B)(4). THE EVENT WAS DESCRIBED AS FOLLOWS: SEVERAL ATTEMPTS WERE MADE TO INSERT A TEE PROBE INTO A PATIENT TO PERFORM A DIAGNOSTIC PROCEDURE. THE EXAM WAS TERMINATED DUE TO THE INABILITY TO INTUBATE THE PATIENT, SO THE PATIENT WAS SENT HOME. A COUPLE OF HOURS LATER, THE PATIENT WENT TO THE EMERGENCY ROOM AFTER COUGHING UP BLOOD. THE ER EXAMINATION DIAGNOSED AN ESOPHAGEAL RUPTURE. THE TRANSDUCER WAS IMMEDIATELY REMOVED FROM SERVICE AND INSPECTED BY THE HOSPITAL BIOMED. THE ENGINEER REPORTED THERE WAS NO MALFUNCTION OF THE TEE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSESOPHAGEAL ENDOSCOPIC TRANSDUCER X7-2T MTEE ITX PHILIPS ULTRASOUND, INC. 453561193192 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other