BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2PSL

    MDR report key: 8080927 · Received November 16, 2018

    Report

    Report Number
    3006182632-2018-00027
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    November 1, 2018
    Report Date
    November 16, 2018
    Manufacturer
    CIRCADIANCE, LLC
    Product Code
    NPF
    UDI-DI
    B0361038140
    PMA / PMN Number
    K061256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920868 SMART MONITOR 2PSL INFANT APNEA MONITOR NPF CIRCADIANCE, LLC 1038140 B0361038140

    Patients

    Seq Age Sex Outcome Treatment
    1