BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JERON

    MDR report key: 4121859 · Received September 22, 2014

    Report

    Report Number
    MW5038350
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 22, 2014
    Manufacturer
    JERON ELECTRONICS
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CODE BLUE BUTTON TESTING FAILED - DID NOT ANNOUNCE THE CODE BLUE. NO HARM TO PT. TESTING WAS ALSO DONE ON 2 ADDITIONAL CODE BUTTONS THAT ALSO FAILED. NO HARM TO PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587622 JERON CALL SYSTEM-CODE BLUE BUTTON ILQ JERON ELECTRONICS 680

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR