BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICENTRAL

    MDR report key: 2152969 · Received June 23, 2011

    Report

    Report Number
    9610105-2011-00018
    Event Type
    Other
    Date Received
    June 23, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 23, 2011
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    MSX
    PMA / PMN Number
    K052972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER (B)(6), PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. REVIEW OF THE ICENTRAL LOG FILES SHOWS THAT THE ICENTRAL PASSWORD PROTECTED AUDIBLE ALARM SETTING WAS SET TO "DISABLED" BY THE USER; THEREFORE, ONLY VISUAL ALARMS WERE PROVIDED AT THE ICENTRAL. NO MALFUNCTION OF THE ICENTRAL OR BEDSIDE MONITOR WAS IDENTIFIED. THE SYSTEM PERFORMED AS DESIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYSTOLE EVENT OCCURRED AND WAS DISCOVERED BY THE NURSE WHEN SHE ENTERED THE ROOM. THE BEDSIDE MONITOR PROVIDED AUDIBLE AND VISUAL ALARMS. THE HOSPITAL STATED THAT THE ALARM WAS NOT NOTICED AT THE ALARM DISPLAY UNIT (ADU) OR AT THE ICENTRAL. THE ALARM HISTORY SHOWS SEVERAL BRADYCARDIA EVENTS PRIOR TO THE ASYSTOLE EVENT. A REVIEW OF THE LOG FILES CONFIRMS THAT THE ICENTRAL AUDIBLE ALARM FUNCTION WAS DISABLED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICENTRAL CLINICAL NETWORK AND CENTRAL STATION MSX GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1 Death