BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    500E INFANT MON. 120V/60HZ

    MDR report key: 249281 · Received November 1, 1999

    Report

    Report Number
    1216774-1999-00006
    Event Type
    Malfunction
    Date Received
    November 1, 1999
    Date of Event
    September 13, 1999
    Report Date
    November 1, 1999
    Manufacturer
    COROMETRICS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AUDIBLE ALARM NOT SOUNDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 500E INFANT MON. 120V/60HZ APNEA MONITOR FLS COROMETRICS MEDICAL SYSTEMS, INC. 500E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *