BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Transducer X7-2t

    MDR report key: 8717966 · Received June 20, 2019

    Report

    Report Number
    3019216-2019-00031
    Event Type
    Injury
    Date Received
    June 20, 2019
    Date of Event
    May 17, 2019
    Report Date
    May 24, 2019
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    ITX
    UDI-DI
    00884838061668
    PMA / PMN Number
    K030455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A THOROUGH INSPECTION WITH FUNCTIONAL AND SAFETY TESTS OF THE INVOLVED TRANSDUCER WAS PERFORMED BY THE LOCAL PHILIPS SERVICE ENGINEER. PROPER FUNCTIONALITY OF THE TRANSDUCER WAS CONFIRMED AND THE DEVICE REMAINS AT THE CUSTOMER SITE. SINCE A RETURN OF THE TRANSDUCER IS NOT EXPECTED, NO ADDITIONAL DEVICE ANALYSIS CAN BE PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DETECTING A PERFORATED ESOPHAGUS AFTER PERFORMING A TRANSESOPHAGEAL (TEE) EXAMINATION USING AN X7-2T MODEL TRANSDUCER WITH AN EPIQ ULTRASOUND SYSTEM. THE PROCEDURE WAS COMPLETED WITHOUT ANY OBSERVED HARM TO THE PATIENT. THE INJURY WAS NOTICED THE NEXT DAY, AND THE PATIENT RECEIVED TREATMENT FOR THE PERFORATED ESOPHAGUS. FURTHER INFORMATION REGARDING THE PATIENT CONDITION POST PROCEDURE WAS NOT DISCLOSED AND THE DEVICE REMAINS AT THE CUSTOMER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509916 Transducer X7-2t ULTRASOUND ITX PHILIPS ULTRASOUND, INC 989605414121 B1ZGZ6 00884838061668

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention