BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 500 INFANT MONITOR

    MDR report key: 145879 · Received January 22, 1998

    Report

    Report Number
    1216774-1998-00001
    Event Type
    Malfunction
    Date Received
    January 22, 1998
    Report Date
    December 18, 1997
    Manufacturer
    COROMETRICS MEDICAL SYS. INC.
    Product Code
    KXN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT REC'D A REPORT FROM THE CAREGIVER OF NO AUDIO ALARM. THE ACCOUNT CONFIRMED THIS REPORT AND RETURNED THE UNIT TO THE MFR FOR REPAIR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *