INVIVO/PHILIPS

Additional Manufacturer Narrative

(B)(4). BASED ON THE PROVIDED INFORMATION AND TEST PERFORMED ON SITE AND AT THE REPAIR FACILITY, IT IS CONCLUDED THAT THE REDDENING OF SKIN AND BLISTERS ON THE LEFT LEG WERE CAUSED BY CONTACT BETWEEN THE COIL CABLE AND THE PATIENTS LEG. THE PADDING THAT WAS PLACED BETWEEN LEG AND CABLE SHIFTED DURING THE EXAMINATION. AS CONTRIBUTING FACTORS WERE IDENTIFIED: A BROKEN TUNING CAPACITOR OF THE COIL USED, THAT MAY HAVE LED TO HIGH CABLE CURRENTS IN CERTAIN SITUATIONS - THE USE OF CONSECUTIVE HIGH SAR SCANS (> 2WKG) - THE ROUTING OF THE CABLE (NOT PARALLEL TO THE BORE, BUT ACROSS). THE INSTRUCTIONS FOR USE CONTAINS EXTENSIVE WARNINGS RELATED TO PATIENT AND COIL/ CABLE POSITIONING. IT IS CLEARLY MENTIONED THAT 2 CM DISTANCE MUST BE KEPT BETWEEN COIL CABLE AND PATIENT.

Additional Manufacturer Narrative

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

Description of Event or Problem

INVIVO/PHILIPS RECEIVED A REPORT FROM A CUSTOMER THAT A BLISTER FORMED ON THE UPPER LEFT THIGH OF A PATIENT AFTER AN MR EXAMINATION. THE PATIENT WAS POSITIONED FEET FIRST FOR AN EXAMINATION OF THE RIGHT KNEE USING THE 8CH KNEE COIL. INJURY WAS CLASSIFIED AS 2ND DEGREE BURN GREATER THAN 2.5CM.