SMART MONITOR 2

Additional Manufacturer Narrative

THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS NOT ABLE TO BE CONFIRMED BECAUSE THE DEVICE HAS NOT BEEN SENT TO CIRCADIANCE FOR EVALUATION. THE CUSTOMER STATED THAT THE DEVICE WILL NOT BE SENT IN FOR SERVICE AND REQUESTED THAT THE COMPLAINT RECORD BE CLOSED. THE SMARTMONITOR 2 DEVICE HAS PROVISIONS TO ALLOW THE USER TO DETECT FAILURE OF THE AUDIBLE ALARM. SPECIFICALLY, THE USERS ARE INSTRUCTED THAT THE AUDIBLE ALARM WILL ANNUNCIATE EVERY TIME THAT THE MONITOR IS TURNED ON ALLOWING THE USER TO VERIFY ALARM FUNCTIONALITY PRIOR TO PLACING THE DEVICE INTO SERVICE. ADDITIONALLY, USERS ARE INSTRUCTED TO PERFORM A FULL DEVICE CHECKOUT BY FOLLOWING THE PUBLISHED SMARTMONITOR 2 CHECKOUT PROCEDURE BETWEEN USES ON DIFFERENT PATIENTS OR AT LEAST ANNUALLY IF THE MONITOR HAS NOT BEEN IN USE. THE STEPS OF THE CHECKOUT PROCEDURE FULLY VERIFY ALL OF THE ALARM FUNCTIONS OF THE SMARTMONITOR 2. THESE INSTRUCTIONS AND FEATURES MINIMIZE THE RISK THAT AN AUDIBLE ALARM FAILURE CAN RESULT IN PATIENT INJURY. THE USER OF THIS EQUIPMENT IS RESPONSIBLE FOR READING, UNDERSTANDING, AND FOLLOWING THE WARNING AND CAUTION STATEMENTS THROUGHOUT THE MANUAL. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE DEVICE IS SENT TO CIRCADIANCE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED.

Description of Event or Problem

CIRCADIANCE, LLC RECEIVED CUSTOMER COMPLAINT ALLEGATION ON (B)(6) 2016 DETAILING A PRODUCT ISSUE ASSOCIATED WITH A SMARTMONITOR 2 DEVICE. THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO ALARM DURING THE FUNCTIONAL SELF-TEST. NO RESULTING EFFECT ON A PATIENT OR POTENTIAL USER HAS BEEN REPORTED.