BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 500E

    MDR report key: 218719 · Received April 9, 1999

    Report

    Report Number
    1216774-1999-00005
    Event Type
    Malfunction
    Date Received
    April 9, 1999
    Report Date
    April 9, 1999
    Manufacturer
    COROMETRICS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MONITOR WAS RECEIVED FOR SERVICING WITH THE STATED SYMPTOM OF "DOES NOT ALARM WHEN UNIT IS FIRST TURNED ON." THE MONITOR IS DESIGNED TO PERFORM A SELF TEST WHEN ITS FIRST TURNED ON. THE AUDIBLE ALARM IS SOUNDED AS PART OF THIS SELF TEST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *