BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 500E INFANT MONITOR

    MDR report key: 109703 · Received July 28, 1997

    Report

    Report Number
    1216774-1997-00006
    Event Type
    Malfunction
    Date Received
    July 28, 1997
    Date of Event
    July 7, 1997
    Report Date
    July 28, 1997
    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

    THE ACCOUNT RETURNED THE MONITOR ON 7/14/97 FOR REPAIR OF "BATTERY WON'T CHARGE AND ALARM NOT FUNCTIONING CONDITIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *