Description of Event or Problem · 0
A. EVENT DESCRIPTION TWO YEARS AGO, A SOFTWARE MALFUNCTION WAS IDENTIFIED IN A SPECIFIC SOFTWARE VERSION OF THE DEVICE UNDER LIMITED AND DEFINED CONDITIONS. IN STRAIN ANALYSIS (MR) (OPTIONAL FUNCTION) ERRORS EXIST IN THE POLAR MAP DISPLAY, GRAPH DISPLAY, AND COLOR MAP DISPLAY OVERLAID ON THE SHORT-AXIS IMAGE FOR THE CALCULATED CIRCUMFERENTIAL STRAIN VALUES. B. PATIENT IMPACT NO PATIENT INJURY, HEALTH DAMAGE, OR DEATH OCCURRED AS A RESULT OF THIS MALFUNCTION. NO ADVERSE EVENTS WERE IDENTIFIED. C. U.S. DISTRIBUTION THE SOFTWARE VERSION INCLUDING THE OPTIONAL FUNCTION WHICH THE MALFUNCTION OCCURRED WAS NOT COMMERCIALLY DISTRIBUTED IN THE UNITED STATES. IN ADDITION, WE CONFIRMED THAT NO SIMILAR DEVICES OR EQUIVALENT CONFIGURATIONS CAPABLE OF REPRODUCING THE MALFUNCTION WERE PRESENT IN THE U.S. MARKET. D. EVALUATION / INVESTIGATION WE CONDUCTED AN INTERNAL EVALUATION AND INVESTIGATION OF THE IDENTIFIED MALFUNCTION. THE INVESTIGATION CONFIRMED THAT THE ISSUE WAS LIMITED TO A SPECIFIC SOFTWARE VERSION AND SPECIFIC OPERATING CONDITIONS. IT WAS DETERMINED THAT THE MALFUNCTION DOES NOT AFFECT PRODUCTS DISTRIBUTED IN THE UNITED STATES MARKET. E. CORRECTIVE AND PREVENTIVE ACTION FOLLOWING IDENTIFICATION OF THE MALFUNCTION, A CORRECTED SOFTWARE VERSION WAS DEVELOPED AND IMPLEMENTED TO ADDRESS THE IDENTIFIED CONDITION. WE CONFIRMED THAT, AS A RESULT OF THIS CORRECTION, THE MALFUNCTION CANNOT OCCUR IN CURRENT OR FUTURE SOFTWARE VERSIONS DISTRIBUTED IN THE UNITED STATES. AS A RESULT, THE POTENTIAL FOR RECURRENCE OF THIS ISSUE IN THE U.S. MARKET HAS BEEN ELIMINATED. F. REASON FOR REPORTING TIMING AT THE TIME THE MALFUNCTION WAS IDENTIFIED, THE AFFECTED SOFTWARE VERSION INCLUDING THE OPTIONAL FUNCTION WAS NOT DISTRIBUTED IN THE UNITED STATES, AND NO U.S. PATIENT EXPOSURE OR ADVERSE EVENTS WERE IDENTIFIED. THEREFORE, THE EVENT WAS NOT CONSIDERED REPORTABLE UNDER U.S. MDR REQUIREMENTS AT THAT TIME.