BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIC PRO CLINICAL INFORMATION CENTER

    MDR report key: 1833833 · Received September 8, 2010

    Report

    Report Number
    2124823-2010-00092
    Event Type
    Other
    Date Received
    September 8, 2010
    Date of Event
    June 23, 2010
    Report Date
    September 8, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K062976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INCLUDED AN EVAL OF LOG FILES AND ON-SITE TESTING OF THE SYSTEM. ANALYSIS OF LOG FILES REVEAL THAT PT MONITORING STARTED AT 20:56:12 AND CONTINUED UNTIL A FINAL ASYSTOLE EVENT AT 22:26:10 ON (B)(6) 2010. AT 21:05:12 (APPROX 9 MINUTES AFTER THE INITIAL ADMIT), THE PT MONITOR DETECTED THAT THE PT WAS IN A LOW SPO2 CONDITION (LESS THAN OR EQUAL TO 90%). THIS WAS ANNOUNCED VISUALLY AND AUDIBLY AT THE CIC AT AN ADVISORY PRIORITY. THE SPO2 LEVEL CONTINUED UNABATED UNTIL 21:10:46 WHEN A FINAL LEVEL OF 78% FOR SPO2 WAS ANNOUNCED. AT THIS TIME, THE PT MONITOR CHANGED FROM A CLINICAL CONDITION TO A TECHNICAL CONDITION OF "SPO2 PROBE." THIS WAS ANNOUNCED AT A SYSTEM ADVISORY LEVEL, WHICH CONTINUED UNTIL 21:58:59 WHEN A "NBP LO 20" EVENT WAS CALLED AT AN ADVISORY PRIORITY, AND FINALLY A VFIB/VTAC AT 21:59:57 AT A CRITICAL PRIORITY. THE BROADCAST OF THE SPO2 EVENTS WERE ANNOUNCED ON ALL CIC'S IN THE CARE AREA VIA BROADCAST ALARMS. NO USER INTERACTIONS SUCH AS SILENCING ALARMS OR CHANGING ALARM PRIORITY LEVELS OCCURRED DURING THE TIME IN QUESTION. ALL SOUNDING AT THE CIC AT THE TIME OF THE EVENT WAS AT 60% VOLUME. FOLLOWING THE EVENT, THE SYSTEM WAS TESTED ON A SIMULATOR IN THE CARE AREA, AND ALARMS WERE NOTED TO BE AUDIBLE. BASED ON THE INVESTIGATION AND INFO AVAILABLE, IT IS BELIEVED THAT THE USER DID NOT RESPOND TO THE CLINICAL EVENTS. THE SYSTEM WAS FOUND TO OPERATE AS DESIGNED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PT EXPIRED. THE PT'S SPO2 AND NIBP WERE BEING MONITORED ON A SOLAR 8000I BEDSIDE AND CIC (CENTRAL STATION) MONITOR. ALARMS WERE REPORTEDLY NOT AUDIBLE AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIC PRO CLINICAL INFORMATION CENTER CENTRAL MONITORING SYSTEM DSI GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death