BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2

    MDR report key: 5871605 · Received August 12, 2016

    Report

    Report Number
    3006182632-2016-00003
    Event Type
    Malfunction
    Date Received
    August 12, 2016
    Report Date
    July 15, 2016
    Manufacturer
    CIRCADIANCE LLC
    Product Code
    FLS
    UDI-DI
    B0364003
    PMA / PMN Number
    K011597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524619 SMART MONITOR 2 APNEA MONITOR FLS CIRCADIANCE LLC 4003 B0364003

    Patients

    Seq Age Sex Outcome Treatment
    1