BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X7-2T TRANSDUCER (MTEE)

    MDR report key: 4337097 · Received December 5, 2014

    Report

    Report Number
    3019216-2014-00028
    Event Type
    Injury
    Date Received
    December 5, 2014
    Report Date
    February 1, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    ITX
    PMA / PMN Number
    K030455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISITING PHYSICIAN TO PHILIPS STATED TO A PHILIPS CLINICAL APPLICATIONS SPECIALIST THAT DURING TEE PROCEDURE IN (B)(6) 2014, AN X7 2T TRANSDUCER MAY HAVE CAUSED SOME HEATING INJURY OF THE ESOPHAGUS OF A PT. IT WAS STATED THAT THE SONOGRAPHER REALIZED THE NEED TO SWITCH OFF THE TRANSDUCER FREQUENTLY TO AVOID INJURY. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO PHILIPS PERSONNEL TO CONFIRM AND GATHER ADD'L DATA RELATED TO THIS EVENT. THE DEVICES INVOLVED IN THIS CASE REMAIN UNK AND NO ADD'L INFO COULD BE OBTAINED.

    Description of Event or Problem · 1

    A PHILIPS APPLICATION SPECIALIST RECEIVED FEEDBACK FROM A DOCTOR OF A (B)(6) HOSP WHO REMARKED THAT DURING A TEE PROCEDURE IN WHICH THE TRANSDUCER WAS ACTIVE FOR 2 HOURS FOR 3D IMAGING, SOME HEATING INJURY OR THE ESOPHAGUS WAS NOTICED IN A PT. IT WAS STATED THAT THE SONOGRAPHER THEN REALIZED THE NEED TO SWITCH OFF THE TRANSDUCER FREQUENTLY TO PREVENT INJURY. THIS FEEDBACK WAS INITIATED AS A RESULT OF A VERBAL COMMENT RECEIVED BY THE DOCTOR DURING A PHILIPS ANDOVER SITE VISIT. DEVICE DETAILS AND SPECIFICS RELATED TO THE PROCEDURE AND DEVICES INVOLVED WERE NOT PROVIDED AND COULD NOT BE OBTAINED. DURING AN INTERNAL AUDIT, IT WAS CONCLUDED THAT PHILIPS' INVESTIGATION DID NOT ADEQUATELY DETERMINE WHETHER A SERIOUS INJURY HAD OCCURRED. BASED UPON THE INABILITY TO DEFINITIVELY VERIFY THE STATED EVENT AND WHETHER A SERIOUS INJURY OCCURRED, A MORE CONSERVATIVE APPROACH IS BEING TAKEN RESULTING IN THE SUBMITTAL OF AN MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786402 X7-2T TRANSDUCER (MTEE) ITX PHILIPS ULTRASOUND, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other