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 FIRST PATIENT. 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. THEREFORE, WE HAVE DECIDE TO REPORT THIS EVENT OUT OF AN ABUNDANCE OF CAUTION.