INGENIA

Additional Manufacturer Narrative

PHILIPS HAS STARTED AN INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

Description of Event or Problem

PHILIPS RECEIVED A REPORT THAT THE PATIENTS ARE EXPERIENCING LETHARGY, NAUSEA, DIZZINESS AND DISCOMFORT AFTER AN EXAM AND HAD THE EXAMS RESCHEDULED. TWO PATIENTS WERE EVALUATED BY EMERGENCY MEDICAL SERVICES (EMS). THE PATIENT AIR VENTILATION WAS CHECKED AND FOUND NO ISSUES. THE SITE WAS CLEARED FOR SCANNING. THIS IS REPORT FOR THE SECOND PATIENT. THE PATIENT WAS ABLE TO COMPLETE SCAN WITHOUT ANY ISSUES. THE PATIENT HAD NO IRREGULARITIES WITH THE EXAM AND LEFT THE FACILITY ON THEIR OWN REFUSING ANY ADDITIONAL TREATMENT. IT IS UNCLEAR IF ANY MEDICAL INTERVENTION WAS PROVIDED FOR PATIENT. BASED ON DETAILS AVAILABLE AT THE TIME OF THIS REVIEW, THERE IS INSUFFICIENT INFORMATION TO DETERMINE WHETHER THE REPORTED HARM MEETS CRITERIA FOR SERIOUS INJURY. DUE TO INSUFFICIENT INFORMATION IN THIS CASE, THE SERIOUS INJURY CANNOT BE RULED OUT. THEREFORE, WE HAVE DECIDE TO REPORT THIS EVENT OUT OF AN ABUNDANCE OF CAUTION.

Additional Manufacturer Narrative

AN INCIDENT WAS REPORTED INVOLVING MAGNET RELATED CONCERNS, WITH A PATIENT REPORTING STRONG MAGNET STRENGTH. THE CUSTOMER INDICATED THAT THE PATIENT EXPERIENCED LETHARGY, NAUSEA, DIZZINESS, AND DISCOMFORT FOLLOWING THE MRI EXAMINATIONS, LEADING TO RESCHEDULING OF EXAMS. THE PATIENT WAS EVALUATED BY EMERGENCY MEDICAL SERVICES (EMS). THE PATIENT AIR VENTILATION WAS CHECKED AND NO ISSUES WERE IDENTIFIED. THE SITE WAS SUBSEQUENTLY CLEARED FOR SCANNING. A PATIENT LATER COMPLETED A SCAN WITHOUT ANY REPORTED ISSUES. MEDICAL TREATMENT AS PROVIDED AS FOLLOWS: EMS WAS DISPATCHED, AND THE PATIENT UNDERWENT EKG, OXYGEN SATURATION, AND BLOOD PRESSURE EVALUATIONS. THE BLOOD PRESSURE OF THE PATIENT WAS FOUND TO BE ELEVATED, AND THE PATIENT LEFT WITH EMS FOLLOWING EVALUATION. AS PART OF THE INVESTIGATION MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION ON THE STATUS OF THE PATIENT, INCLUDING DIRECT CONTACT WITH THE CUSTOMER. NO INFORMATION WAS MADE AVAILABLE REGARDING ANY FURTHER MEDICAL INTERVENTION BEYOND THE INITIAL ASSESSMENTS. NO FURTHER ADDITIONAL INFORMATION REGARDING THIS INCIDENT HAS BEEN RECEIVED. ONSITE EVALUATION OF THE SYSTEM SHOWED NO ABNORMALITIES, NOT IN THE LOGFILES NOR IN THE OVERALL PERFORMANCE OF THE SYSTEM. AFTER OUR INVESTIGATION AND ANALYSIS, IT WAS CONCLUDED THAT THE MR SYSTEM USED IN THIS CASE WAS WORKING CORRECTLY. THERE IS NO INDICATION OF A MALFUNCTION OF THE MR SYSTEM USED THAT COULD HAVE CONTRIBUTED TO THE INCIDENT. THE PATIENT EXPERIENCING LETHARGY AND DIZZINESS WAS MOST LIKELY CAUSED BY THE HIGH B0 FIELD (3TESLA) STRENGTH OF THE MAGNET. SENSITIVITY TO THE MAGNETIC FIELD STRENGTH CAN VARY FROM PERSON TO PERSON. THIS IS AN INHERENT PART OF MAGNETIC RESONANCE IMAGING, THERE ARE NO MITIGATIONS AVAILABLE TO PREVENT THIS FROM OCCURRING.

Description of Event or Problem

PHILIPS RECEIVED A REPORT THAT 2 PATIENTS EXPERIENCED LETHARGY, NAUSEA, DIZZINESS AND DISCOMFORT AFTER AN EXAM AND HAD THE EXAMS RESCHEDULED. THIS IS THE REPORT FOR PATIENT 2. THE PATIENT WAS EVALUATED BY EMERGENCY MEDICAL SERVICES (EMS). THE PATIENT AIR VENTILATION WAS CHECKED AND FOUND NO ISSUES. THE SITE WAS CLEARED FOR SCANNING. THE PATIENT WAS ABLE TO COMPLETE SCAN WITHOUT ANY ISSUES. MEDICAL TREATMENT PROVIDED AS FOLLOWS: EMS WAS DISPATCHED TO TAKE CARE OF THE PATIENT. THE PATIENT LEFT EMS AFTER TAKING EKG, O2 AND BLOOD PRESSURE EXAMS. BLOOD PRESSURE WAS ELEVATED. IT IS UNCLEAR WHICH MEDICAL INTERVENTION WAS PROVIDED FOR PATIENT. BASED ON DETAILS AVAILABLE AT THE TIME OF THIS REVIEW, THERE IS INSUFFICIENT INFORMATION TO DETERMINE WHETHER THE REPORTED HARM MEETS CRITERIA FOR SERIOUS INJURY. DUE TO INSUFFICIENT INFORMATION IN THIS CASE, THE SERIOUS INJURY CANNOT BE RULED OUT.