BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRITICAL CARE ALERT

    MDR report key: 17710738 · Received September 8, 2023

    Report

    Report Number
    17710738
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    July 16, 2023
    Report Date
    August 16, 2023
    Manufacturer
    INTEGO SOFTWARE, LLC D/B/A CRITICAL ALERT
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FAILURE OF CALL LIGHT SYSTEM WHEN PRESSED FOR TEAM OB/NEONATAL CODE DID NOT ALARM FROM ROOM OR OVERHEAD. THE TONES ARE VERY SIMILAR AND HAVE BEEN TESTED AND EDUCATED ON. THERE IS VERY LITTLE DIFFERENCE IN THE TONES AS WELL AS THE SOUND VERY SIMILAR TO CRITICAL ALERTS OF TELEMETRY MONITORS AND ALARIS PUMP ALARMS IN LABOR AND DELIVERY AND EMERGENCY DEPARTMENT LOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112713 CRITICAL CARE ALERT SYSTEM, COMMUNICATION, POWERED ILQ INTEGO SOFTWARE, LLC D/B/A CRITICAL ALERT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown