BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTMONITOR 2

    MDR report key: 5018686 · Received August 11, 2015

    Report

    Report Number
    3006182632-2015-00001
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    June 29, 2015
    Report Date
    August 11, 2015
    Manufacturer
    CIRCADIANCE LLC
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALARM MODULE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. RESULTS OF THAT ANALYSIS WILL BE PROVIDED IN A FOLLOW UP REPORT. 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 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.

    Additional Manufacturer Narrative · 1

    CIRCADIANCE, LLC HAS COMPLETED ITS INVESTIGATION OF THE SMARTMONITOR 2 DEVICE. THE INVESTIGATION CONCLUDED THAT THE IDENTIFIED ISSUE WAS ASSOCIATED WITH A QUALITY MANUFACTURING ISSUE PREVIOUSLY IDENTIFIED BY THE SUPPLIER OF THE COMPONENT. THE SUPPLIER HAD IMPLEMENTED A CORRECTIVE ACTION ASSOCIATED WITH THIS FAILURE AND DETERMINED THAT THE CORRECTIVE ACTION WAS EFFECTIVE. 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 A COMPLETE REVIEW OF THE COMPLAINT ALLEGATION AND THE SUPPLIER'S CORRECTIVE ACTION, IT HAS BEEN CONCLUDED THAT THE IDENTIFIED FAILURE IS NOT CONSIDERED TO BE A SYSTEMIC ISSUE AND THAT THE ASSOCIATED RISK HAS BEEN FOUND TO BE ACCEPTABLE. COMPLAINT TRACKING AND TRENDING WILL CONTINUE TO BE MONITORED ON A PERIODIC BASIS. CIRCADIANCE, LLC HAS DETERMINED THAT NO FURTHER INVESTIGATION OR ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CIRCADIANCE, LLC RECEIVED A CUSTOMER COMPLAINT ON (B)(6) 2915 WHERE IT WAS ALLEGED THAT A SMARTMONITOR 2 UNIT WAS NOT PRODUCING AN AUDILE ALARMING. THE UNIT WAS SENT BACK TO CIRCADIANCE. UPON INSPECTION OF THE DEVICE, IT WAS DETERMINED THAT THE DEVICE WAS NOT PRODUCING AN AUDIBLE ALARM. A CIRCADIANCE REPRESENTATIVE CONTACTED THE CUSTOMER TO GET ADDITIONAL DETAILS. THE CUSTOMER DID NOT KNOW IF THE DEVICE WAS IN USE AT THE TIME THE PROBLEM WAS DISCOVERED AND NO PATIENT HARM WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525687 SMARTMONITOR 2 APNEA MONITOR FLS CIRCADIANCE LLC 4002

    Patients

    Seq Age Sex Outcome Treatment
    1