BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSDUCER, ULTRASONIC, DIAGNOSTIC

    MDR report key: 7060504 · Received November 27, 2017

    Report

    Report Number
    3019216-2017-00039
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    March 5, 2015
    Report Date
    October 31, 2017
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTS FOR MORE INFORMATION WERE SUBMITTED WHICH RESULTED IN VERIFICATION THE PATIENT¿S ESOPHAGUS WAS RESECTED TO TREAT THE INJURY. ADDITIONAL DETAILS COULD NOT BE OBTAINED; SERIAL NUMBERS FOR BOTH SYSTEM AND TRANSDUCER INVOLVED IN THE INCIDENT WERE REQUESTED, BUT COULD NOT BE CONFIRMED. AS A RESULT, NO FAILURE ANALYSIS COULD BE PERFORMED TO DETERMINE THE CAUSE OF THE PATIENT INJURY. NO ADDITIONAL INFORMATION COULD BE OBTAINED FOR THIS EVENT. ADDITIONAL DETAILS COULD NOT BE OBTAINED; SERIAL NUMBERS FOR BOTH SYSTEM AND TRANSDUCER INVOLVED IN THE INCIDENT WERE REQUESTED, BUT COULD NOT BE CONFIRMED. AS A RESULT, NO FAILURE ANALYSIS COULD BE PERFORMED TO DETERMINE THE CAUSE OF THE PATIENT INJURY.

    Description of Event or Problem · 1

    A CUSTOMER INFORMED THEIR LOCAL FIELD SERVICE ENGINEER OF AN EVENT THAT OCCURRED APPROXIMATELY TWO YEARS AGO INVOLVING A PATIENT INJURY THAT HAD NOT PREVIOUSLY BEEN REPORTED TO PHILIPS. A MONTH AFTER UNDERGOING A TRANSESOPHAGEAL (TEE) PROCEDURE USING PHILIPS DEVICES, A PATIENT CLAIMED THEY SUFFERED BURNS TO THEIR THROAT WHICH MAY HAVE BEEN CAUSED BY THE TEE EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839370 TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX PHILIPS ULTRASOUND, INC B134ZM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention