BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVENT-LINK 511 APNEA MONITOR

    MDR report key: 438462 · Received January 14, 2003

    Report

    Report Number
    2244861-2003-00002
    Event Type
    Malfunction
    Date Received
    January 14, 2003
    Date of Event
    December 1, 2002
    Report Date
    January 14, 2003
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    NO SOUND FROM THE MONITOR'S AUDIBLE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVENT-LINK 511 APNEA MONITOR BREATHING FREQUENCY MONITOR FLS CAS MEDICAL SYSTEMS, INC. 511 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN