BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE

    MDR report key: 14159630 · Received April 20, 2022

    Report

    Report Number
    14159630
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    February 3, 2021
    Report Date
    April 13, 2022
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DINAMAP WORKS INTERMITTENTLY. USING THEM IN COVID PATIENTS AND DOES NOT CONSISTENTLY WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2719370 CARESCAPE MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. V100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown