FRU, HEADNECKSPINE COIL 1.5T

Additional Manufacturer Narrative

(B)(4). METHOD: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA. RESULTS: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA. CONCLUSION: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

Additional Manufacturer Narrative

(B)(4). BASED ON THE PROVIDED INFORMATION AND TEST PERFORMED ON SITE THERE IS NO INDICATION OF A MALFUNCTION OF THE MR SYSTEM OR COIL. IT IS CONCLUDED THAT THIS HEATING INCIDENT IS A SKIN TO SKIN HEATING INCIDENT CAUSED BY A RF CURRENT LOOP FORMATION INSIDE THE LEFT ARM PIT OF THE PATIENT. NO PADDING WAS USED BETWEEN THE ARMS AND SIDE OF THE PATIENT TO PREVENT SKIN-SKIN CONTACT. IN THIS CASE SEVERAL FACTORS WERE OBSERVED THAT CONTRIBUTED TO THE SUSTAINED INJURY: THE PATIENT WAS OBESE AND COVERED BY A COTTON SHEET, 4 SCANS ON HIGH SAR VALUE WERE CONDUCTED AND THE TOTAL DELIVERED SPECIFIC ENERGY DOSE (SED) WAS 3726 J/KG.

Description of Event or Problem

A MALE PT WAS POSITIONED HEAD FIRST SUPINE AND SCANNED WITH THE DS NVC COIL FOR A CERVICAL SPINE EXAMINATION. THE PT EXPERIENCED A HEATING SENSATION AND AFTER THE EXAMINATION REDDENING OF THE SKIN AND 2 BLISTERS OF 3/4 INCH WERE OBSERVED IN THE PTS LEFT ARM PIT.