BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAS INFANT APNEA MONITOR

    MDR report key: 2074970 · Received April 26, 2011

    Report

    Report Number
    MW5020423
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    March 11, 2011
    Report Date
    April 26, 2011
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    NPF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MONITOR DID NOT ALARM FOR AN APNEA EVENT, HOWEVER, THE INDICATOR LIGHT FOR APNEA WAS ON. DATES OF USE: (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Disability