BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAC-LAB

    MDR report key: 11894201 · Received May 27, 2021

    Report

    Report Number
    11894201
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    April 29, 2021
    Report Date
    May 17, 2021
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GE MEDICAL SYSTEMS (B)(6) SHUTS DOWN PARTIALLY WITHOUT WARNING WITH PATIENT ON TABLE. HEALTH CARE PROVIDERS ARE UNABLE TO RESTART AUTO VITALS, UNABLE TO RECORD PRESSURES, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790106 MAC-LAB COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA