MAGNETOM AERA

Additional Manufacturer Narrative

E1: THE FACILITY CONTACT LAST NAME WAS NOT PROVIDED FOR REPORTING. H3, H6: THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL REPORTABLE INFORMATION AND/OR INVESTIGATION COMPLETION. H6: COMPONENT CODE "TRANSMITTER" WAS CHOSEN FOR RF TRANSMIT/RECEIVE COIL FOR MRI. COMPONENT IS A FOOT/ANKLE BODY MRI COIL.

Description of Event or Problem

SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT INJURY ASSOCIATED WITH A MAGNETOM AREA SYSTEM. IT WAS COMMUNICATED THAT THE PATIENT WAS BURNED. ALTHOUGH SIEMENS HEALTHINEERS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE NATURE AND EXTENT OF THE PATIENT¿S BURN INJURY, A RESPONSE HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.