BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE HEALTHCARE TECHNOLOGY CSCS V3

    MDR report key: 18273908 · Received December 5, 2023

    Report

    Report Number
    MW5148828
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    December 1, 2023
    Report Date
    December 1, 2023
    Manufacturer
    GE HEALTHCARE TECHNOLOGY / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    GE HEALTHCARE CARESCAPE CENTRAL STATION VERSION 3. DURING EQUIPMENT RESTART OR LOSS OF POWER, THE CLINICAL APPLICATION WILL FAIL TO START, CAUSING A LOSS OF PATIENT MONITORING. THE RECOMMENDED FIX BY GE HEALTHCARE IS TO SHIP THE UNIT TO THEIR REPAIR DEPOT TO HAVE THE 2082301-005 FRU MP200X COMM EXPRESS MODULE REPLACED; 4 OF 24 (16%) OF THE DEVICES CURRENTLY IN USE HAVE BEEN OBSERVED WITH THE ISSUE. DEVICES HAVE BEEN IN USE FOR APPROXIMATELY 1.5 YEARS FROM GE INSTALLATION DATE. REFERENCE REPORTS MW5148829, MW5148830, MW5148831.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584230 GE HEALTHCARE TECHNOLOGY CSCS V3 DETECTOR AND ALARM, ARRHYTHMIA DSI GE HEALTHCARE TECHNOLOGY / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MAI800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other