BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMI PLUS APNEA MONITOR

    MDR report key: 2481326 · Received February 28, 2012

    Report

    Report Number
    MW5024510
    Event Type
    Injury
    Date Received
    February 28, 2012
    Date of Event
    February 8, 2012
    Report Date
    February 28, 2012
    Manufacturer
    CAS MEDICAL SYSTEMS INC.
    Product Code
    NPF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT SHE FOUND THE CHILD TURNING BLUE BUT THAT THE APNEA MONITOR DID NOT AUDIBLY ALARM, NOR PROVIDE A VISUAL INDICATOR OF APNEA. DATES OF USE: (B)(6) 2012 - CURRENTLY BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMI PLUS APNEA MONITOR APENA MONITOR NPF CAS MEDICAL SYSTEMS INC. AMIPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S