BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 538598 · Received April 19, 2004

    Report

    Report Number
    538598
    Event Type
    Other
    Date Received
    April 19, 2004
    Date of Event
    March 1, 2004
    Report Date
    March 1, 2004
    Manufacturer
    CAS MEDICAL SYSTEMS
    Product Code
    NPF
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PT'S FAMILY MEMBER REPORTED AN "INCIDENT" WHERE THE PT'S LIP TURNED BLUE AND PARAMEDICS WERE CALLED. THE FAMILY MEMBER STATES THE ALARM ON THE MONITOR DID SOUND. THE FAMILY MEMBER CALLED IN FOR A DOWNLOAD OF THE MONITOR AND THE DOWNLOAD DID NOT SHOW THE INCIDENT. THE MONITOR WAS EXCHANGED AND RETURNED TO THE FACILITY. THE PRINTED REPORT INCLUDES A "PT REPORT" THAT SHOWS A HIGH HEART RATE ALARM AT THE SPECIFIED TIME BUT DOES NOT SHOW ANY CORRESPONDING WAVE FORMS. THE MONITOR IS BEING SENT TO CAS MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * AMI APNEA MONITOR NPF CAS MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR