BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    500E INFANT MONITOR

    MDR report key: 87692 · Received April 24, 1997

    Report

    Report Number
    1216774-1997-00004
    Event Type
    Malfunction
    Date Received
    April 24, 1997
    Date of Event
    April 9, 1997
    Report Date
    April 22, 1997
    Manufacturer
    COROMETRICS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE MONITOR WILL NOT ALARM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 500E INFANT MONITOR CARDIO-RESPIRATORY MONITOR FLS COROMETRICS MEDICAL SYSTEMS, INC. 05500E *

    Patients

    Seq Age Sex Outcome Treatment
    1 *