BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HFL38/13-6 MH TRANSDUCER

    MDR report key: 4455698 · Received January 17, 2015

    Report

    Report Number
    3032367-2015-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2015
    Date of Event
    December 17, 2014
    Report Date
    January 16, 2015
    Manufacturer
    FUJIFILM SONOSITE, INC
    Product Code
    ITX
    PMA / PMN Number
    K053069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HFL38 TRANSDUCER WAS USED WITH A MICROMAXX ULTRASOUND SYSTEM (PART NUMBER P08840-22, SERIAL NUMBER (B)(4). A FOLLOW UP REPORT(S) WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIVING MISSING OR NEW INFO. THE FOLLOWING FIELDS ARE EXPECTED TO THE COMPLETED OR UPDATES WITH THE NEXT REPORT(S): (SERIAL NUMBER - THE CUSTOMER HAS NOT PROVIDED THE SERIAL NUMBER OF THE TRANSDUCER. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE FROM THE CUSTOMER FOR EVAL.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT TWO (2) DAYS AFTER A CAROTID SCAN ON BOTH SIDES OF THE PT'S NECK, THE PT CALLED TO REPORT THAT THEY HAD EXPERIENCED A BURN ON THE LOCATION WHERE THE SCAN HAD OCCURRED. THE BURN WAS ONLY EXPERIENCED ON THE LEFT SIDE OF THE PT'S NECK. AN HFL38 TRANSDUCER ATTACHED TO A MICROMAXX ULTRASOUND SYSTEM WAS USED TO CONDUCT THE EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42467 HFL38/13-6 MH TRANSDUCER DIAGNOSTIC ULTRASONIC TRANSDUCER ITX FUJIFILM SONOSITE, INC P07632-70

    Patients

    Seq Age Sex Outcome Treatment
    1 Other