BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMRI SYSTEM-AUDIOSYSTEM

    MDR report key: 6063033 · Received October 28, 2016

    Report

    Report Number
    3006738448-2016-00001
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    December 11, 2015
    Report Date
    October 28, 2016
    Manufacturer
    NORDICNEUROLAB AS
    Product Code
    LNH
    PMA / PMN Number
    K092253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL CONCERNED DEVICES HAVE BEEN RETURNED AND REPLACED ACCORDINGLY. (MIDDLE OF JANUARY 2016 TO FIRST WEEK OF FEBRUARY 2016). THE DEVICE THAT WAS DETECTED IN AT (B)(6) WAS RETUNED AND ALL RELATED DEVICE IN (B)(6) HAS BEEN UN-INSTALLED. THE HOSPITAL IS NO LONGER USING THE DEVICE. OUR INVESTIGATION HAVE LEAD TO LIKELY HYPOTHESIS, BUT UNABLE TO REPRODUCE THE ISSUE AND LACK OF ACCESS TO AN EQUIVALENT SYSTEM. WE HAVE DECIDED TO NOT CONTINUE THE INVESTIGATION ANY FURTHER. ALL AFFECTED UNITS HAVE BEEN RETUNED AND REPLACED ACCORDINGLY.

    Description of Event or Problem · 1

    HEATING OF AUDIO SYSTEM. WE HAD BEEN NOTIFIED OF AN INCIDENT WHERE THE CABLE OF THE NNL HEADPHONE HEATED DURING AN EXAMINATION. IT WAS REPORTED THAT AFTER A PATIENT SCAN, THE OPERATOR IDENTIFIED THAT THE HEADPHONE CABLE HAD BECOME HEATED. NO INJURY WAS REPORTED TO THE PATIENT OR THE OPERATOR. HOWEVER, IT WAS REPORTED THE CABLE WAS SUFFICIENTLY HEATED TO BECOME UNCOMFORTABLE TO TOUCH, WITH THE POTENTIAL TO CAUSE INJURY. THE NNL AUDIOSYSTEM IN QUESTION, HAD HAD A MODIFIED HEADPHONE (A SET OF RESISTORS LOCATED AT THE CONNECTOR OF THE HEADPHONE CABLE). THE INCIDENT OCCURRED ON THE 1.5T SCANNER (PHILIPS) DURING A SPINE EXAMINATION IN A HOSPITAL IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714217 FMRI SYSTEM-AUDIOSYSTEM AUDIOSYSTEM-HEADPHONE LNH NORDICNEUROLAB AS HEADPHONE

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other