FDA Adverse Event Summary report: N

GE 450 W MRI SCANNER 1.5 TESLA MAGNET UNK

MDR report key: 7973490 · Received October 16, 2018

Report

Report Number
MW5080598
Date Received
October 16, 2018
Date of Event
October 13, 2018
Report Date
October 15, 2018
Manufacturer
GENERAL ELECTRIC CO.
Product Code
LNH
Report Source
Voluntary report
Reporter Location
WA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

MRI TECHNOLOGIST, (B)(6), HAD AN OUTPATIENT ON SATURDAY (B)(6) 2018 FOR 3 MRIS, A BRAIN WITH AND WITHOUT, A THORACIC WITH AND WITHOUT, AND A CERVICAL WITH AND WITHOUT. (B)(6) SAID THE PT FELT A WARMING / BURNING SENSATION ON THE TOP OF HER HEAD DURING HER MRI EXAM. THE TECHNOLOGIST CHECKED THE PT'S HEAD AND SHE SEEMED FINE AND THE SCAN ROOM FAN WAS TURNED ALL THE WAY UP. THE PT WAS UNABLE TO FINISH ALL 3 MRIS ORDERED, WHICH WAS A BRAIN, CERVICAL THORACIC ALL WITH AND WITHOUT CONTRAST. SHE WAS ONLY ABLE TO DO THE BRAIN WITHOUT AND THORACIC WITHOUT. THE THORACIC WITHOUT WAS DONE FIRST, FOLLOWED BY THE BRAIN. SHE RETURNED MONDAY (B)(6) 2018 TO FINISH HER EXAMS. WHEN I OBSERVED HER ON (B)(6) 2018 BEFORE HER MRI SHE HAD A SMALL RED AREA, THE SIZE OF HALF OF A PENCIL ERASER TOP ON HER SCALP. I ASKED THE RADIOLOGIST, DR (B)(6). IF IT WAS OKAY TO DO HER MRI THAT DAY. HE SAID YES AND TO CHECK ON THE PT AFTER EVERY SEQUENCE AND TO STOP IMMEDIATELY IF SHE FELT ANY BURN/WARMING SENSATION. THE PT HAD HER MRI ON (B)(6) 2018 WITH NO COMPLAINTS. SHE HAD HER BRAIN WITH CONTRAST, THORACIC WITH CONTRAST AND CSPINE WITH AND WITHOUT CONTRAST ON (B)(6) 2018. IT WAS CONFIRMED THAT THE PT HAD NO METAL OR PREVIOUS SURGERY IN THAT AREA, PT'S HAIR WAS NOT WET AND SAR LEVELS WERE CHECKED AND CONFIRMED THAT THE PT WAS SCANNED ON NORMAL MODE. THE SECOND TIME SHE CAME, SHE WAS DONE ON OUR SIEMENS MRI INSTEAD OF THE GE MRI SCANNER SHE WAS ORIGINALLY ON.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
812726 GE 450 W MRI SCANNER 1.5 TESLA MAGNET UNK SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH GENERAL ELECTRIC CO.

Patients

Seq Age Sex Outcome Treatment
1 58 YR Other