BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2

    MDR report key: 5773073 · Received July 6, 2016

    Report

    Report Number
    3006182632-2016-00002
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Report Date
    June 6, 2016
    Manufacturer
    CIRCADIANCE LLC.
    Product Code
    FLS
    UDI-DI
    B0364003
    PMA / PMN Number
    K011597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO CIRCADIANCE FOR INVESTIGATION. THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS CONFIRMED DURING THE EVALUATION OF THE DEVICE. 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 THE TRANSDUCER HOOK-UP WIRE SOLDERING TO THE BRASS CONNECTION OF THE TRANSDUCER BEING BROKEN. THE ROOT CAUSE OF THE IDENTIFIED ISSUE HAS BEEN DETERMINED TO BE POOR SOLDERING WORKMANSHIP AND PREVIOUSLY ADDRESSED BY THE ALARM MANUFACTURER'S CORRECTIVE ACTION PROCESS IN MAY OF 2015. ACTIONS INITIATED BY THE MANUFACTURER CONSISTED OF A SPECIFIED PROCEDURE FOR BOTH THE SOLDERING OF WIRES TO THE TRANSDUCERS AND QUALITY INSPECTION OF TRANSDUCER SOLDER CONNECTIONS FOR AUDIBLE ALARMS SPECIFICALLY MANUFACTURED FOR USE IN THE SMART MONITOR 2 DEVICE. 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 INSTRUCTIONS 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. NO OTHER ADDITIONAL ALARM FAILURES ASSOCIATED WITH THE IDENTIFIED ROOT CAUSE HAVE BEEN REPORTED TO CIRCADIANCE SINCE ACQUIRING THE SMART MONITOR DEVICE IN JULY OF 2015. A REVIEW OF COMPLAINT DATA PROVIDED BY PHILIP'S HEALTHCARE, THE PREVIOUS MANUFACTURER OF THE SMART MONITOR 2, SHOWED THREE PREVIOUS OCCURRENCES OF THE IDENTIFIED ISSUE HAD OCCURRED PRIOR TO CIRCADIANCE ACQUIRING THE PRODUCT LINE. THESE OCCURRENCES PROMPTED A CORRECTIVE ACTION BY THE AUDIBLE ALARM MANUFACTURER IN MAY OF 2015. NONE OF THE REPORTED FAILURES RESULTED IN PATIENT HARM AND ALL OF THE FAILURES WERE IDENTIFIED EITHER DURING THE START-UP DIAGNOSTIC OR DURING THE SMART MONITOR CHECKOUT PROCEDURE PRIOR TO THE DEVICE BEING FULLY PLACED INTO PATIENT USE. BASED ON THESE FINDINGS AND A COMPLETE REVIEW OF THIS COMPLAINT FILE, IT IS CONCLUDED THAT 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 ON A PERIODIC BASIS.

    Description of Event or Problem · 1

    CIRCADIANCE, LLC RECEIVED CUSTOMER COMPLAINT ALLEGATION ON (B)(6) 2016 FROM A DURABLE MEDICAL EQUIPMENT (DME) PROVIDER DETAILING AN AUDIBLE ALARM FAILURE ASSOCIATED WITH A SMARTMONITOR 2 DEVICE. THE CUSTOMER REPORTED THAT FAILURE OCCURRED WHEN HOOKING UP THE DEVICE TO THE PATIENT AND THE DEVICE FAILED TO PRODUCE AN AUDIBLE ALARM DURING THE START-UP SELF-TEST DIAGNOSTIC. NO RESULTING EFFECT ON A PATIENT OR POTENTIAL USER HAS BEEN REPORTED. VISUAL ALARM INDICATORS WERE REPORTEDLY FUNCTIONING BOTH AT PATIENT'S HOME AND ON THE SIMULATOR BACK IN THE OFFICE DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425834 SMART MONITOR 2 APNEA MONITOR FLS CIRCADIANCE LLC. 4003 B0364003

    Patients

    Seq Age Sex Outcome Treatment
    1