BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTMONITOR 2 W/O MODEM

    MDR report key: 5284898 · Received December 10, 2015

    Report

    Report Number
    3006182632-2015-00004
    Event Type
    Malfunction
    Date Received
    December 10, 2015
    Date of Event
    November 6, 2015
    Report Date
    November 13, 2015
    Manufacturer
    CIRCADIANCE, LLC
    Product Code
    FLS
    UDI-DI
    B0364002
    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

    CIRCADIANCE, LLC HAS COMPLETED ITS INVESTIGATION OF THE SMARTMONITOR 2 PRODUCT FAILURE DETAILED IN THE INITIAL MEDWATCH SUBMISSION. THE INVESTIGATION CONCLUDED THAT THE IDENTIFIED ISSUE COULD NOT BE SUBSTANTIATED BY THE COMPONENTS MANUFACTURER. TESTING OF THE COMPONENT CONCLUDED THAT IT WAS FOUND TO OPERATE AND PERFORM TO SPECIFICATION. NO OPERATIONAL ISSUES SIGNIFYING A MALFUNCTION WERE RECORDED DURING THE MANUFACTURER'S INVESTIGATION. THE OPERATOR'S MANUAL RECOMMENDS THAT BEFORE YOU USE THE SMART MONITOR 2, TEST TO SEE IF YOU CAN HEAR THE ALARM IN DIFFERENT ROOMS WHILE THERE IS NOISE IN YOUR HOUSE. THE OPERATOR'S MANUAL RECOMMENDS TO ALWAYS KEEP THE AREA IN FRONT OF THE SPEAKER CLEAR AND TO TURN THE MONITOR ON (WITHOUT THE CHILD ATTACHED) TO SOUND THE ALARM, MAKING SURE YOU CAN HEAR THE ALARM IN DIFFERENT AREAS OF YOUR HOME. CIRCADIANCE HAS DETERMINED THAT BASED ON A COMPLETE REVIEW OF THE AVAILABLE INFORMATION, 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.

    Description of Event or Problem · 1

    CIRCADIANCE, (B)(4) RECEIVED A CUSTOMER COMPLAINT ON (B)(6) 2015 WHERE IT WAS ALLEGED THAT A SMARTMONITOR 2 UNIT WAS NOT PRODUCING AN AUDIBLE ALARM. THE UNIT WAS SENT BACK TO CIRCADIANCE, (B)(4). UPON INSPECTION OF THE DEVICE, IT WAS DETERMINED THAT THE DEVICE WAS PRODUCING AN AUDIBLE ALARM; HOWEVER, THE ALARM SOUND WAS DISTORTED. THE CUSTOMER STATED THAT THE DEVICE WAS IN USE AT THE TIME THE PROBLEM WAS DISCOVERED AND NO PATIENT OR USER HARM WAS ALLEGED OR HAD OCCURRED. THE ALARM MODULE HAS BEEN RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. RESULTS OF THE INVESTIGATION 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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815743 SMARTMONITOR 2 W/O MODEM APNEA MONITOR FLS CIRCADIANCE, LLC 4002 B0364002

    Patients

    Seq Age Sex Outcome Treatment
    1