Description of Event or Problem · 1
WE HAD AN INCIDENT WITH A PRODUCT THAT OUR PATIENTS USE WHILE THEY ARE UNDERGOING AN MRI SCAN. THE PRODUCT IS THE CINEMAVISION MRI COMPATIBLE HIGH RESOLUTION AUDIO/VIDEO GOGGLE SYSTEM. IT IS MANUFACTURED BY RESONANCE TECHNOLOGY INC. WE HAD A PATIENT THAT WAS HAVING CERVICAL, THORACIC, AND LUMBAR MRI SCANS. THE CERVICAL SCAN WAS COMPLETED WITHOUT INCIDENT. AFTER THE THORACIC SCAN, I BROUGHT THE PATIENT OUT OF THE MRI UNIT TO SET HIM UP FOR THE LUMBAR SCAN. WHEN I BROUGHT THE PATIENT OUT, HE STATED THAT HE FELT HOT AND I NOTICED THAT HIS FACE WAS SWEATY. I REACHED UP TO TAKE OFF THE HEADSET AND VIDEO GOGGLES AND NOTICED THAT THE PART OF THE HEADSET THAT WAS OVER THE PATIENT'S RIGHT EAR WAS VERY HOT. I LOOKED AT THE HEADSET ON THAT SIDE AND NOTICED THAT THE INSULATION ON ONE OF THE WIRES WAS MISSING IN SEVERAL AREAS AND THAT SAME WIRE WAS STUCK TO A SEPARATE WIRE IN TWO SPOTS. I FEEL THAT THE WIRE BECAME HOT FOR SOME REASON AND MELTED THE INSULATION. THE PATIENT DIDN'T SUFFER ANY HARMFUL EFFECTS FROM THIS INCIDENT BUT I FEEL THAT THE POTENTIAL EXISTED FOR THE HEADSET TO CATCH FIRE OR TO BECOME HOT ENOUGH TO BURN THE PATIENT WITHOUT CATCHING ON FIRE. WE TOOK THE UNIT OUT OF SERVICE AND RESONANCE TECHNOLOGY LATER REPLACED THE SYSTEM. WE DON'T KNOW AS YET IF RESONANCE TECHNOLOGY WAS ABLE TO DISCOVER THE CAUSE OF THE PROBLEM.