Description of Event or Problem · 1
CIRCADIANCE, LLC RECEIVED A CUSTOMER COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT (DME) PROVIDER DETAILING AN AUDIBLE ALARM FAILURE ASSOCIATED WITH A SMARTMONITOR 2 DEVICE. THE CUSTOMER REPORTED FAILURE OCCURRED WHEN DURING THE START-UP SELF-TEST DIAGNOSTIC AT A PATIENT'S HOME PRIOR TO PLACING THE DEVICE INTO USE. NO RESULTING EFFECT ON A PATIENT OR POTENTIAL USER HAS BEEN REPORTED. VISUAL ALARM INDICATORS WERE FUNCTIONING BOTH AT THE PATIENT'S HOME AND ON THE SIMULATOR BACK AT THE OFFICE DURING TESTING. THE DEVICE WAS RETURNED TO CIRCADIANCE FOR INVESTIGATION. THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS CONFIRMED DURING THE EVALUATION OF THE DEVICE (MARCH 27TH, 2019). AN ALARM FAILURE ASSOCIATED WITH A FAULTY AUDIBLE ALARM WAS RECORDED. THE AUDIBLE ALARM WAS SENT TO BE EVALUATED BY THE MANUFACTURER AND THE FAILURE MODE WAS CONFIRMED. THE AUDIBLE ALARM WAS FOUND NOT TO PRODUCE ANY SOUND DUE TO A POOR SOLDER CONNECTION BETWEEN OF WIRE TO THE BRASS SECTION OF A TRANSDUCER. THE ROOT CAUSE HAS BEEN DETERMINED TO BE SOLDER DROP ON TRANSDUCER AND THE WIRE OF THE TRANSDUCER. ACTIONS INITIATED BY THE MANUFACTURER CONSISTED OF A DEDICATED PROJECT THAT HAD ALREADY BEEN INITIATED IN THE 3RD QUARTER OF 2018, WHICH IDENTIFIED MANUFACTURING PROCESSES IMPROVEMENTS TO INCREASE THE SOLDERING PROCESS RELIABILITY AND TO INCREASE THE FINISHED SOLDER JOINT STRENGTH. 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 THE ALARM FUNCTIONALITY PRIOR TO PLACING THE DEVICE INTO SERVICE. ADDITIONALLY, USERS ARE INSTRUCTED TO PERFORM A FULL DEVICE CHECKOUT PROCEDURE 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 THAN AN AUDIBLE ALARM FAILURE CAN RESULT IN PATIENT INJURY. THE INSTRUCTION AND FEATURES NOTIFIED THE CAREGIVER AND SUBSEQUENTLY RETURNED THE DEVICE FOR SERVICING. THE USER OF THIS EQUIPMENT IS RESPONSIBLE FOR READING, UNDERSTANDING, AND FOLLOWING THE WARNING AND CAUTION STATEMENTS THROUGHOUT THE MANUAL. THE FAILURE OF THE DEVICE HAD BEEN PREVIOUSLY IDENTIFIED IN THE PRODUCT'S RISK ANALYSIS AND PRODUCT LABELING. AN EVALUATION OF THE RISK ASSOCIATED WITH THE IDENTIFIED FAILURE HAS DETERMINED THAT THERE IS NO NEW OR INCREASED RISK TO THE PATIENT OR USER AND THAT NO ADDITIONAL RISK REDUCTION IS NECESSARY. BASED ON THESE FINDING AND A COMPLETE REVIEW OF THIS COMPLAINT FILE, IT IS CONCLUDED THAT THE USE OF THE DEVICE DOES NOT PRESENT AN INCREASED RISK TO THE END USER OR PATIENT AND THAT NO CORRECTIVE ACTION OR ADDITIONAL INVESTIGATION ACTIVITY IS NECESSARY AT THIS TIME. COMPLAINT CODE TRENDING WILL CONTINUE TO BE REVIEWED AT CIRCADIANCE ON A PERIODIC BASIS.