SIGNA PET/MR

Additional Manufacturer Narrative

COMMON DEVICE NAME: TOMOGRAPHIC IMAGER COMBINING EMISSION COMPUTED TOMOGRAPHY WITH NUCLEAR MAGNETIC RESONANCE. UNIQUE IDENTIFIER: (B)(4). THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN MRI OF THE INTERNAL AUDITORY CANALS (IACS) TO EVALUATE A PRE-EXISTING CONDITION OF LEFT SIDED VESTIBULAR SCHWANNOMA AND LEFT SIDE HEARING LOSS. THE PATIENT WAS PROVIDED APPROPRIATE EARPLUGS BY THE CUSTOMER FOR THE EXAM. THE PATIENT RETURNED TO THE RADIOLOGY DEPARTMENT AFTER THE MRI EXAM HAD BEEN COMPLETED TO REPORT HEARING LOSS IN THE RIGHT EAR. THE PATIENT WAS EVALUATED BY THE SITE'S AUDIOLOGY DEPARTMENT WHERE NEW HEARING LOSS IN THE RIGHT EAR WAS CONFIRMED AND MEDICATION WAS PROVIDED FOR TREATMENT. THE PATIENT'S CONDITION IS CONFIRMED TO HAVE FULLY RESOLVED TO PRIOR BASELINE.

Additional Manufacturer Narrative

THE INVESTIGATION BY GE HEALTHCARE HAS BEEN COMPLETED. THE ACOUSTIC PERFORMANCE TEST WAS PERFORMED ON THE SYSTEM AND CONCLUDED THAT THE TESTING MEETS THE IEC 60601-2-33 REQUIREMENTS AND THE OSHA LEVELS ARE WITHIN THE SPECIFICATION FOR THIS SYSTEM CONFIGURATION. THE INCIDENT APPEARS TO BE THE RESULT OF HUMAN MEDICAL CONDITION(S). THE PATIENT WAS PROVIDED SPECIFIED HEARING PROTECTION; HOWEVER, A PATIENT'S MEDICAL CONDITIONS MAY CAUSE SENSITIVITY TO ACOUSTIC LEVELS THAT OCCUR DURING NORMAL CLINICAL SCANNING. NO SYSTEM ISSUE WAS FOUND. NO CORRECTIONS ARE REQUIRED AS THE SYSTEM WAS OPERATING WITHIN SPECIFICATION.