BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4X COMFORT HEADSET

    MDR report key: 2706524 · Received August 1, 2012

    Report

    Report Number
    2029299-2012-00002
    Event Type
    Malfunction
    Date Received
    August 1, 2012
    Date of Event
    July 3, 2012
    Report Date
    August 1, 2012
    Manufacturer
    RESONANCE TECHNOLOGY, INC.
    Product Code
    LNH
    PMA / PMN Number
    K994351
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS. FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT NOTICED HEATING DURING SCAN (MAINLY AT END SCAN) WITH HEATING ON RIGHT SIDE OF FACE. PATIENT THOUGHT ABOUT SQUEEZING BUZZER BUT DID NOT. THE T2 COR AND SAG SPAIR WERE BOTH REPEATED BY TECHNOLOGIST TO IMPROVE IMAGE QUALITY. TECHNOLOGIST SPOKE TO PATIENT TO ENSURE PATIENT COMFORT AND INFORM THE PATIENT OF THE NECESSITY OF THE REPEATED SCANS. PATIENT DID NOT COMPLAIN OF HEATING OR PAIN (DID NOT SQUEEZE BUZZER). PATIENT HABITUS SMALL. ONLY AT END OF SCAN WAS RADIOGRAPHER AWARE OF THE HEATING FELT BY THE PATIENT. THE BURN WAS ON THE RIGHT SIDE OF THE FACE IN THE SHAPE OF A SMALL CRESCENT OF APPROXIMATELY 20MM LONG BY 5MM WIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4X COMFORT HEADSET LNH RESONANCE TECHNOLOGY, INC. RTC-650-060-000-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention