BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEO-TRAK 502 INFANT MONITOR

    MDR report key: 134603 · Received November 20, 1997

    Report

    Report Number
    1216774-1997-00010
    Event Type
    Malfunction
    Date Received
    November 20, 1997
    Date of Event
    October 7, 1997
    Report Date
    October 7, 1997
    Manufacturer
    COROMETRICS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    MONITOR RETURNED TO THE MFR FOR REPAIR OF LOCK-UP CONDITION. WHEN THE MONITOR WAS REPAIRED THE SERVICE TECHNICIAN NOTED THAT THE MONITOR DID NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEO-TRAK 502 INFANT MONITOR ECG/RESPIRATION MONITOR FLS COROMETRICS MEDICAL SYSTEMS, INC. 502 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *