FDA Adverse Event Malfunction Summary report: N

MRI MACHINE

MDR report key: 3221716 · Received July 7, 2013

Report

Report Number
MW5030823
Event Type
Malfunction
Date Received
July 7, 2013
Date of Event
July 5, 2013
Report Date
July 7, 2013
Product Code
LNH
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AZ, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

I HAD BEEN EXPERIENCING SEVERE LOWER BACK PAIN FOR OVER A WEEK. IT WAS SO BAD I HAD ALREADY MADE ON VISIT TO THE EMERGENCY ROOM AT THE (B)(6) CLINIC. AFTER A FOLLOW-UP VISIT WITH MY PRIMARY CARE DOCTOR, DR (B)(6), HE GAVE ME A HOMEOPATHIC SHOT (WHICH DIDN'T DO ANY GOOD) AND WANTED ME TO FOLLOW-UP BY HAVING AN MRI OF MY LUMBAR SPINE, SACRUM AND PELVIS. HE TOLD ME (B)(6) IMAGING WOULD CALL TO SET UP AN APPOINTMENT. ON (B)(6) 2013, IS WAS CALLED AR 4:55PM. I WAS NOT HOME AT THE TIME AND (B)(6) WAS THE (B)(6). I RETURNED THE CALL ON (B)(6) IN THE MORNING TO (B)(6) IMAGING TO SEE IF THERE WAS ANY WAY I COULD GET IN THAT DAY TO THEIR (B)(6) LOCATION (WHERE I HAVE ALWAYS GONE IN THE PAST) AND THEY TOLD ME THEY NEEDED AND HOUR AND A HALF FOR MY TEST AND THEY DIDN'T HAVE ANY OPENING THERE. THEY OFFERED TO SEND ME TWO OTHER LOCATIONS THAT WERE FAR FROM WHERE I LIVED, AND I WAS IN TOO MUCH PAIN TO DRIVE THAT FAR AND DIDN'T HAVE ANYONE AT HOME TO TAKE ME. SO I HUNG UP WITH THE SCHEDULER AND CALLED BACK AND ASKED WHO THE MANAGER WAS OF SCHEDULING. I WAS TOLD "(B)(6)" AND I ASKED TO SPEAK TO EITHER ONE. THE NEXT THING THAT HAPPENED WAS SOMEONE ANSWERED THE PHONE (A WOMAN) AND I ASKED HER NAME AND WHAT HER POSITION WAS. SHE TOLD ME HER NAME WAS "(B)(6)" (SP?) AND HER POSITION WAS (B)(6). I TOLD HER THAT I WAS IN EXCRUCIATING PAIN (THE TRUTH) AND WAS THERE ANY WAY I COULD GET INTO THE (B)(6) LOCATION THAT DAY FOR AN MRI? SHE ASKED THAT I HOLD ON WHILE SHE CHECKED. SHE CAME BACK TO THE PHONE AND TOLD ME THERE WAS NOTHING OPEN THERE AND COULD UNDERSTAND THE OTHER TWO OTHER LOCATIONS I WAS OFFERED WERE TOO FAR FOR ME TO TRAVEL, BUT SHE OFFERED ME ANOTHER LOCATION AT (B)(6), AND AFTER QUESTIONING HER ABOUT EXACTLY WHERE THAT LOCATION WAS, I TOLD HER I NEVER KNEW THEY HAD A LOCATION THERE BUT I WOULD BE GLAD TO GO THERE SINCE IT WASN'T REAL FAR FROM WHERE I LIVED. THE APPOINTMENT WAS SET UP FOR 1:00. WHEN I GOT TO THE BUILDING, IT HAD A SIGN OUTSIDE READING "(B)(6) IMAGING" AND THERE WERE ONLY TWO PEOPLE THERE - A GIRL AT THE FRONT DESK AND THE TECH WHO WAS GOING TO DO THE MRI. I THOUGHT IT WAS ODD THAT NO OTHER PTS WERE THERE. THE GIRL AT THE FRONT DESK TOLD ME THEY OPENED THE PLACE FOR ME THAT DAY, OTHERWISE NO ONE WOULD HAVE BEEN THERE . AGAIN, I THOUGHT THAT WAS ODD. I QUESTIONED THE GIRL ABOUT HOW LONG HAD THEY BEEN IN THE LOCATION, SINCE I NEVER HEARD ABOUT THAT LOCATION BEFORE AND SHE TOLD ME THEY'VE BEEN THERE ABOUT A YEAR BUT IT WAS SOLD TO AN ORTHOPEDIC PRACTICE. AGAIN, I THOUGH IT WAS ODD. SO THE TECH INFORMED ME THAT IT WOULD BE AN HOUR AND A HALF TEST AND I WAS OKAY WITH THAT, SINCE I WAS IN SEVERE PAIN - WANTED TO GET IT OVER WITH SO I COULD FIND OUT WHAT WAS WRONG. WHILE I WAS IN THE MACHINE, I NOTICED MY UNDERSIDE - THE ENTIRE BACK SIDE OF MY BODY WAS GETTING VERY, VERY HOT. THAT HAS NEVER HAPPENED TO ME BEFORE AND I'VE HAD SEVERAL MRI'S THROUGHOUT MY LIFE. I FIGURED I WOULD TRY TO DEAL WITH IT, BUT I ALSO NOTICED IMMEDIATELY WHEN I WAS PUT INTO THE MACHINE, THERE WAS NEXT TO NO AIR CIRCULATING ABOVE MY FACE, WHICH I ALSO THOUGHT WAS ODD SINCE THE ROOM IS USUALLY FREEZING COLD AND THE PTS GET LOTS OF AIR ON THEIR FACE. AS THE TEST PROGRESSED, I REALIZED I COULD BARELY BREATHE DUE TO THE LACK OF AIR ABOVE ME (I HAVE ADVANCED COPD) AND MY BACKSIDE WAS REALLY HOT AND BURNING. I PRESSED THE PANIC BUTTON AND TOLD THE GIRL I WAS FINISHED! SHE PULLED ME OUT OF THE MACHINE AND I TOLD HER THE MACHINE WAS BURNING MY ENTIRE BACKSIDE AND THERE WAS JUST ABOUT NO AIR CIRCULATING ABOVE ME. SHE TOLD ME THE FAN ON THE MACHINE WAS ON AND THE MACHINE HEATS UP AFTER BEING ON THAT LENGTH OF TIME. THEN SHE TOLD ME THAT SHE WAS GOING TO CALL THE REPAIRMAN BECAUSE THE ROOM WAS WARM AND IT SHOULD HAVE BEEN COOLER WHICH WOULD HAVE KEPT THE MACHINE COOLER. I ASKED HER HOW LONG I WAS IN THE MACHINE AND SHE SAID, "FIFTY-FIVE MINUTES." SHE TOLD ME THE LAST PART OF THE EXAM ON MY PELVIS SHE WAS UNABLE TO FINISH. I TOLD HER THAT I HAVE NEVER ASKED TO COME OUT OF A MACHINE BEFORE EARLY AND I'VE HAD SEVERAL MRI'S AND I'VE NEVER EXPERIENCED HAVING MY BACKSIDE VERY, VERY HOT BEFORE, IN ADDITION TO NOT HAVING ANY AIR CIRCULATION STRONGLY BLOWING ABOVE ME. SHE HAD NO RESPONSE TO THAT. I CHANGED BACK TO MY CLOTHES FROM THE GOWN, WENT UP TO THE FRONT DESK TO GET A COPY OF THE MRI REPORT OF MY BACK THAT I HAD REQUESTED AND I TOOK ONE OF THEIR BUSINESS CARDS AND LEFT. LATER AT HOME I NOTICED THE LOCATION I WAS AT IS NOT LISTED AS ONE OF THEIR LOCATIONS ON THEIR BUSINESS CARD, EVEN THOUGH THEY LIST A TOTAL OF 12 LOCATIONS. MRI MACHINE WAS BURNING THE BACKSIDE OF MY BODY. THERE WAS VERY LITTLE AIR CIRCULATING IN THE MACHINE AND ABOVE MY HEAD AND BODY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
308202 MRI MACHINE MRI MACHINE LNH

Patients

Seq Age Sex Outcome Treatment
1 67 YR Other MAGNESIUM| VAGIFEM 25MCG| DULERA 400MCG/5MCG| FISH OIL| RESTASIS 0.4| VANICREAM HC 2.5%| KLONOPIN| DIOVAN (VE) 80| NEXIUM 40| TOPROL XL (1/2) 25| SPIRIVA HANDIHALER| VITAMIN C| VITAMIN D| ACIDOPHILIS