BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 500E INFANT MONITOR

    MDR report key: 126215 · Received October 1, 1997

    Report

    Report Number
    1216774-1997-00008
    Event Type
    Malfunction
    Date Received
    October 1, 1997
    Date of Event
    September 18, 1997
    Manufacturer
    COROMETRICS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE MONITOR WAS RETURNED FOR REPAIR OF LOW HEART RATE ALARMS OF 70,80, AND 90 BEATS PER MINUTE. THE MONITOR DOES NOT ALARM AT THESE SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 500E INFANT MONITOR INFANT ECG/RESPIRTAION MONITOR FLS COROMETRICS MEDICAL SYSTEMS, INC. 500E *

    Patients

    Seq Age Sex Outcome Treatment
    1 *