BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE CENTRAL STATION V2

    MDR report key: 7120459 · Received December 15, 2017

    Report

    Report Number
    7120459
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    December 7, 2017
    Report Date
    December 13, 2017
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    DXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TELEMETRY CENTRAL MONITORING STATION TURNED OFF AND CAME BACK UP BY ITSELF. PER CLINICAL STAFF NO ONE WAS NEAR THE DEVICE, OR INTERACTING WITH IT AT THE TIME. WHEN THE CENTRAL MONITORING STATION CAME BACK UP, IT FAILED TO ESTABLISH A CONNECTION WITH THE MONITORING NETWORK. AS A RESULT, TWO PATIENTS ON THE FLOOR WHO WERE BEING MONITORED FOR CENTRAL TELEMETRY MONITORING COULD NOT BE MONITORED. PATIENTS WERE TRANSFERRED TO A DASH 4000 PHYSIOLOGICAL MONITOR UNTIL THE ON-CALL TECHNICIAN COULD COME AND FIX THE CENTRAL MONITOR. THE CENTRAL MONITOR WAS SUBSEQUENTLY PULLED FROM SERVICE THE FOLLOWING MORNING AND REPLACED WITH A LOANER UNIT. LOGS WERE PULLED AND SENT TO THE GE ENGINEERING TEAM FOR REVIEW. MANUFACTURER RESPONSE FOR CENTRAL CARDIAC MONITOR, GE (PER SITE REPORTER): THEY ARE ESCALATING THE ISSUE WITH THEIR ENGINEERING TEAM FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899712 CARESCAPE CENTRAL STATION V2 COMPUTER, DIAGNOSTIC, PROGRAMMABLE DXG GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR PATIENT WAS CONNECTED TO GE WIRELESS TELEMETRY SYS