BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 500EXL INFANT MONITOR

    MDR report key: 147113 · Received January 29, 1998

    Report

    Report Number
    1216774-1998-00002
    Event Type
    Malfunction
    Date Received
    January 29, 1998
    Report Date
    January 8, 1998
    Manufacturer
    COROMETRICS MEDICAL SYSTEMS, INC.
    Product Code
    KXN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE CAREGIVER PHONED THE ACCOUNT AND REPORTED THAT THE MONITOR WAS ON AN INFANT AND DID NOT ALARM. THE MONITOR PASSED ALARM TESTS AT THE ACCOUNT. THE ACCOUNT NOTED THAT THE RESET SWITCH DID NOT CLEAR THE ALARM LIGHTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *