MRI 3 T TESLA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-13 for MRI 3 T TESLA manufactured by .

Event Text Entries

[57805830] I am copying the letter that was sent to (b)(6), march 6, 2015, (b)(6). (b)(6). To whom it may concern, this letter is regarding my mri/mra brain imaging study conducted on saturday, (b)(6) 2015 in (b)(6). The mri machine is a 3tesla. My appointment was scheduled at 0945, and i was escorted back at that time so as to secure my clothes and valuables in a locker and to have contrast injected. The tech assistant injected my contrast competently and professionally. Shortly thereafter, the mri imaging tech brought me back to the mri room, questioned me as to area of interest, had me lie down on the scanner table, put a wedge under my knees, handed me ear plugs which i put in, secured my head in the immobilization device, covered me with a blanket, and gave me the "communication hub" to hold in my left hand. The scan began and was completed in approx 45 minutes. I left the imaging room, gathered my things, and left the building. I received a telephone call from (b)(6) approx one hour after i had left your facility, asking me to return as not all of the images "came out. " i returned and asked that had happened. The mri tech who was very rushed, said that he had rebooted the machine that morning, but not all of my images came out. He asked if i had pain in the right side of my face. He got me back on the table, affixed the head immobilizer, and slid the table into the mri tube. I did not get earplugs nor the "communication hub. " i yelled several times while i was in the mri tube, but to no avail. This scan was completed in about 15 minutes. When the tech got me out of the tube, i told him that he had not given me ear protection nor the hub. He did look sorry and apologized. Immediately after the scan, i experienced severe tinnitus and to this day. I am experiencing severe tinnitus. As a direct pt health care provider myself, i would most certainly think, he would have documented his error in not giving the pt appropriate medical treatment/protection. Alas, upon my return to (b)(6) to pick up an add'l disc of my brain scan on (b)(6) 2015, i asked to speak with the supervisor, (b)(6). She looked up the scan and was unable to identify the tech who had given me the scan, and also noted that there was no tech documentation on the failure to give me ear protection nor hand "panic". (b)(6). My medical appointment with ent specialist, dr. (b)(6) on (b)(6) 2015, revealed mild to moderate hearing loss at the upper khz. This is due to the high pitched ringing tinnitus i am experiencing, thus, i am unable to hear the high pitched tones provided by dr. (b)(6) audiologist. Suffice to say, i am certainly upset by this turn of events and would like some feedback from you. Very truly yours, (b)(6). Additionally, i had appointments with (b)(6), dds ((b)(6) 2015). Dr. (b)(6) ((b)(6) 2015 and ongoing). (b)(6), aud ((b)(6) 2015), (b)(6), md otoneurologist and ((b)(6) 2015), and (b)(6), aud ((b)(6) 2015). The diagnoses of hearing loss, hyperacusis, and tinnitus were made. My concerns are the lack of qa in this facility, technologist incompetency with failure to report an error, and the obvious malfunctioning of the mri's communication to their computer's hard drive.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5065451
MDR Report Key6033677
Date Received2016-10-13
Date of Report2016-10-13
Date of Event2015-01-31
Date Added to Maude2016-10-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMRI 3 T TESLA
Generic NameMRI 3 T TESLA
Product CodeMOS
Date Received2016-10-13
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2016-10-13

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