BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EARLY RESPONSE SYSTEM

    MDR report key: 4253548 · Received November 6, 2014

    Report

    Report Number
    MW5039060
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 27, 2014
    Report Date
    November 6, 2014
    Manufacturer
    JERON
    Product Code
    ILQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CALL LIGHT OVER HEAD PAGE DID NOT OPERATE TO NOTIFY STAFF OF CODE BLUE. THE SOFTWARE HAD BEEN TESTED 30 DAYS PRIOR. IT WAS NOTED AFTER THE CODE BY THE NURSING SUPERVISOR AND OTHER STAFF THAT THEY DIDN TO HEAR AN OVERHEAD PAGE OF THE CODE BLUE. THE RN SUPERVISOR NEARBY ENTERED THE ROOM WHEN SHE SAW THE OUTSIDE SIREN LIGHT FLASHING. AFTER THE EVENT, THE SUPERVISOR WAS ASKED BY THE AOC TO TEST SEVERAL ROOMS TO SEE IF THE PAGER SYSTEM WAS WORKING AND IT WAS NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714368 EARLY RESPONSE SYSTEM EARLY RESPONSE SYSTEM ILQ JERON 680

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention