BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARESCAPE PRO CLINICAL INFORMATION CENTER (CIC)

    MDR report key: 4773800 · Received May 12, 2015

    Report

    Report Number
    4773800
    Event Type
    Death
    Date Received
    May 12, 2015
    Date of Event
    April 6, 2015
    Report Date
    April 27, 2015
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    MSX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A TELEMETRY PATIENT CONTINUED TO EXPERIENCE LEADS OFF WITHOUT RE-NOTIFICATION TO THE TEAM. A LEADS FAILED WAS SENT AT ~1601 BUT NEVER AGAIN. THE LEADS HAD BEEN REPLACED BY THE RN AT AROUND 1900. THE PATIENT WAS FOUND AT 2025 NON-RESPONSIVE BUT A LEADS FAILED ALARM WAS NEVER SENT AGAIN (LAST ONE BEING ~1601). WHEN THE PATIENT WAS FOUND, THE LEADS WERE OFF OF THE BODY. IN ADDITION, THE ASCOM SYSTEM WENT DOWN AND WAS NOT SENDING ALARMS TO THE PCT (PATIENT CARE TECHNICIAN) PHONES. ACCORDING TO THE CIC (CLINICAL INFORMATION CENTER) LOG THERE WERE NO ALARMS THAT WERE APPEARING ON THE CIC AS INDICATED ON THE LOG. (CIC HAD THE ABILITY TO BE DISABLED). WE CANNOT SAY FOR CERTAIN IF AFTER THE LEADS WERE REPLACED ANOTHER ALARM WENT TO THE SANDS PORTABLE TELEPHONE DEVICE TO INDICATE A LEADS OFF ALARM OR ANY OTHER ALARM. SANDS DEVICES DID NOT HAVE A BUILT IN ESCALATION FOR "TECHNICAL ALARMS". ANOTHER CONCERN IS THAT WHEN AN ALARM IS SILENCED AT THE CIC IT SILENCES ALL ALARMS--THIS SHOULD NOT BE AN OPTION. SILENCING ONE ALARM SHOULD ONLY ALLOW YOU TO SILENCE THAT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310901 CARESCAPE PRO CLINICAL INFORMATION CENTER (CIC) DETECTOR AND ALARM, ARRHYTHMIA MSX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MP100D *
    310902 TELLIGENCE; UNITE CONNECT FOR NURSE CALL SYSTEM, ENVIRONMENTAL CONTROL, POWERED IQA GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death PORTABLE TELEPHONE DEVICES SPECTRA LINKS| ASCOMCIC MACHINEGE TELEMETRY SYSTEMSANDS