SIGNA PET/MR

Additional Manufacturer Narrative

THE INVESTIGATION BY GE HEALTHCARE HAS BEEN COMPLETED. ACOUSTIC MEASUREMENTS WERE PERFORMED ON THE PET/MR SYSTEM AND BASED ON THE TESTING COMPLETED, IT WAS CONCLUDED THAT THE PET/MR SYSTEM MET THE (B)(4) REQUIREMENTS AND OSHA LEVELS. THE SYSTEM WAS OPERATING WITHIN THE REGULATORY LIMITS. SYSTEM LOGS WERE REVIEWED AND NO UNUSUAL ERRORS THAT MAY HAVE INDICATED GRADIENT SUBSYSTEM FAILURES OR OTHER CONTRIBUTING FACTORS TO POTENTIAL HIGH ACOUSTIC NOISE WERE IDENTIFIED. THE LIKELY PRIMARY ROOT CAUSE OF THIS EVENT IS A PATIENT MEDICAL CONDITION THAT CAUSED SENSITIVITY TO ACOUSTIC LEVELS. NO SYSTEMIC PRODUCT ISSUE WAS IDENTIFIED. HOWEVER, DUE TO THE ADDITIONAL ENGINEERING INVESTIGATION THAT WAS PERFORMED, THE CUSTOMER¿S GRADIENT COIL WAS REPLACED.

Additional Manufacturer Narrative

THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. TOMOGRAPHIC IMAGER COMBINING EMISSION COMPUTED TOMOGRAPHY WITH NUCLEAR MAGNETIC RESONANCE 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 INITIALLY REPORTED THAT A PATIENT, WHO WAS WEARING EAR PLUGS, COMPLAINED OF NOT BEING ABLE TO HEAR AFTER A MRI EXAM. THE PATIENT WAS SENT TO THE SITE'S NURSING STATION FOR CARE, HOWEVER NO DETAILS WERE PROVIDED THAT THE PATIENT REQUIRED OR RECEIVED MEDICAL TREATMENT. THE SITE FOLLOWED UP THE FOLLOWING DAY AND THE PATIENT SAID THAT IT HAD IMPROVED BUT NOT FULLY. THE CUSTOMER LATER CONFIRMED THAT THE PATIENT HAD MILD SENSORINEURAL HEARING LOSS AT 2 KHZ IN THE RIGHT EAR. BASELINE HEARING WAS NOT KNOWN.