BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2

    MDR report key: 8102283 · Received November 26, 2018

    Report

    Report Number
    3006182632-2018-00028
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    November 1, 2018
    Report Date
    November 16, 2018
    Manufacturer
    CIRCADIANCE, LLC
    Product Code
    FLS
    UDI-DI
    B0364002
    PMA / PMN Number
    K011597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MONITOR IS THE HOME VERSION OF THE SMART MONITOR 2 AND THE JACK ON THE BACK OF THE MONITOR IS FOR INTERFACING TO A PREVIOUSLY SOLD REMOTE ALARM FOR HOME USE. THIS JACK IS NOT OPERABLE WITH A NURSE CALL SYSTEM. THE USER FACILITY HAS BEEN INFORMED THAT THIS INTERFACE SHOULD NOT BE USED WITH A NURSE CALL SYSTEM AS IT IS NOT INTENDED FOR THAT PURPOSE.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT THE NURSE CALL JACK ON THE MONITOR WAS NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941563 SMART MONITOR 2 INFANT APNEA MONITOR FLS CIRCADIANCE, LLC 4002 B0364002

    Patients

    Seq Age Sex Outcome Treatment
    1