BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE CENTRAL STATION

    MDR report key: 11027135 · Received December 17, 2020

    Report

    Report Number
    11027135
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 16, 2020
    Report Date
    December 9, 2020
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STAFF REPORTED THAT THE CENTRAL STATION MADE A LOUD POPPING NOISE AND THEN THE SCREEN WENT BLACK. THIS RESULTED IN A LOSS OF CENTRALIZED PATIENT MONITORING. THE CENTRAL MONITOR WAS REPLACED AND UPON FURTHER INSPECTION, AN ISSUE WITH THE POWER SUPPLY WAS IDENTIFIED. THE MANUFACTURER RESPONDED TO THIS EVENT. GE FIELD ENGINEER HAS BEEN ON-SITE TO EVALUATE THE POWER SUPPLY AND BEGIN INVESTIGATION ON ROOT CAUSE. GE HAS PROVIDED INTERIM LOANER CENTRAL STATION UNTIL THE ISSUE IS RESOLVED AND HOSPITAL OWNED CENTRAL STATIONS ARE FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493652 CARESCAPE CENTRAL STATION COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. V2 INTEGRATED MAI 700

    Patients

    Seq Age Sex Outcome Treatment
    1