BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2

    MDR report key: 7826643 · Received August 29, 2018

    Report

    Report Number
    3006182632-2018-00024
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 3, 2018
    Report Date
    August 28, 2018
    Manufacturer
    CIRCADIANCE, LLC
    Product Code
    FLS
    UDI-DI
    B0364003
    PMA / PMN Number
    K011597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALARM MODULE MANUFACTURER REVIEWED PRODUCTION RECORDS FOR THE LOT OF MODULES ASSOCIATED WITH THE FAILED ALARM BUZZER. ALL BUZZERS PASSED FACTORY TESTING AND NO OTHER FAILURES HAVE BEEN RECEIVED FROM THIS LOT. THE MANUFACTURER DETERMINED THAT THE APPROPRIATE CORRECTIVE ACTION FOR THIS ISSUE WAS TO RE-TRAIN THE OPERATOR AS THIS SOLDER JOINT IS A MANUAL OPERATION. BASED ON THE FACT THAT ONLY ONE BUZZER FROM THIS LOT HAS FAILED, NO FURTHER ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE SMART MONITOR 2 DEVICES INCORPORATE A START UP SEQUENCE WHERE ALL AUDIBLE AND VISUAL ALARM INDICATORS ARE ACTIVATED TO ALLOW A USER TO VERIFY THAT ALL OF THESE ELEMENTS FUNCTION CORRECTLY EVERY TIME THE MONITOR IS TURNED ON TO BE PUT INTO SERVICE. THE DEVICE THAT IS THE SUBJECT OF THIS REPORT WAS NOT IN PATIENT USE WHEN THE AUDIBLE ALARM FAILURE WAS DETECTED SUGGESTING THAT THE START UP SEQUENCE DOES PROVIDE AN APPROPRIATE MEANS FOR THE USER TO DETERMINE WHETHER OR NOT THE MONITOR'S ALARM SYSTEMS ARE FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    A USER FACILITY CONTACTED CIRCADIANCE ON (B)(6) 2018 AND REPORTED THAT THE AUDIBLE ALARM IN THE MONITOR WAS NOT FUNCTIONING. THE MONITOR WAS NOT BEING USED WITH A PATIENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667608 SMART MONITOR 2 INFANT APNEA MONITOR FLS CIRCADIANCE, LLC 4003 B0364003

    Patients

    Seq Age Sex Outcome Treatment
    1