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Patient 1
THE DEVICE ASSOCIATED WITH THIS EVENT WAS SENT DIRECTLY FROM THE USER FACILITY TO A CERTIFIED, INDEPENDENT LABORATORY ((B)(6)) FOR TESTING. THE TESTING WAS PERFORMED IN ACCORDANCE WITH A PROTOCOL PROVIDED BY SYNAPSE BIOMEDICAL INC. THE PROTOCOL AND SUMMARY OF THE RESULTS OBTAINED ARE PROVIDED. THE FINAL REPORT HAS NOT BEEN COMPLETED BUT WILL BE SUBMITTED IN A FOLLOW-UP REPORT, WHICH WILL CONTAIN DETAILS FOR EACH TEST CONDUCTED. SYNAPSE BIOMEDICAL INC. HAS NO FURTHER DETAILS REGARDING THE ADVERSE EVENT OTHER THAN THOSE PRESENTED IN THE USER FACILITY REPORT. WE HAVE HAD NO CONTACT WITH THE PATIENT'S FAMILY OR ANYONE ELSE DIRECTLY INVOLVED AND IT SHOULD BE NOTED THAT THE PATIENT WAS NOT AT THE USER FACILITY AT THE TIME OF THE INCIDENT. THE ONLY MECHANISM FOR DEVICE SHUTDOWN IS A MECHANICAL SWITCH THAT REQUIRES TWO BUTTONS ON THE FRONT OF THE DEVICE TO BE PRESSED SIMULTANEOUSLY. THE RETURNED DEVICE WAS FOUND TO OPERATE WITHIN SPECIFICATIONS AND THE EVENTS DESCRIBED IN THE USER FACILITY REPORT COULD NOT BE REPRODUCED. MANUFACTURE AND TEST RECORDS INDICATE THE DEVICE WAS ASSEMBLED ACCORDING TO CONTROLLED, PREDEFINED PROCEDURES AND ALL TESTING MET SPECIFICATION. THERE WERE NO ERRORS OR DEVIATIONS FOUND IN THE DEVICE HISTORY RECORD NOR ANY INDICATION THAT THE DEVICE WAS DEFECTIVE IN ANY WAY. A FINAL CONCLUSION WILL BE INCLUDED WITH THE FOLLOW-UP REPORT BUT AT THIS TIME WE HAVE IDENTIFIED NO DEFECTS WITH THE DEVICE, IT PERFORMS WITHIN SPECIFICATIONS AND WE HAVE NOT BE ABLE TO REPRODUCE THE ADVERSE EVENT AS DESCRIBED IN THE USER FACILITY REPORT.