INGENIA

Additional Manufacturer Narrative

NO FUNCTIONAL TESTS WERE PERFORMED AS THIS ISSUE WAS CAUSED BY A USE ERROR BY BRINGING A NON MR SAFE WHEELCHAIR INTO THE EXAMINATION ROOM. BASED ON THE PROVIDED INFORMATION THERE IS NO INDICATION OF A MALFUNCTION OF THE MRI SYSTEM. THE ROOT CAUSE OF THIS INCIDENT IS DETERMINED TO BE A USE ERROR. THE USER DID NOT FOLLOW THE INSTRUCTION FOR USE "IFU SECTION MAGNET SAFETY - ACCESS TO CONTROLLED ACCESS AREA". IT IS A KNOWN ISSUE THAT NO MAGNETIC MATERIALS SHOULD BE BROUGHT INTO THE EXAMINATION ROOM.

Description of Event or Problem

PHILIPS RECEIVED A REPORT THAT A WHEELCHAIR MADE UP OF FERROUS MATERIAL WAS BROUGHT INTO THE MR ROOM. THE USER WAS INJURED WHEN THE MAGNETIC WHEELCHAIR BECAME STUCK WHILE APPROACHING THE MAGNET. AS A RESULT, THE USER SUSTAINED BRUISES AND ABRASIONS. THE USER WAS SENT TO EMERGENCY DEPARTMENT OF HOSPITAL. THE REPORTED INJURY WAS SUPERFICIAL IN NATURE, CONSISTING ONLY OF MINOR ABRASIONS AND BRUISES, AND FULL RECOVERY IS EXPECTED. THE CUSTOMER HAS CHOSEN NOT TO PROVIDE INFORMATION REGARDING THE USER INVOLVED INCLUDING REGION, SIZE, OR LOCATION OF THE INJURY, NOR ANY INFORMATION ABOUT THE MEDICAL INTERVENTIONS PROVIDED. WE HAVE DECIDE TO REPORT THIS EVENT OUT OF AN ABUNDANCE OF CAUTION.