BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MACUVE360

    MDR report key: 18384000 · Received December 21, 2023

    Report

    Report Number
    MW5149478
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    November 20, 2023
    Report Date
    December 20, 2023
    Manufacturer
    \GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERE IS A DELAY IN PART ORDER THAT RESULTED IN DELAY IN REPAIRING THE MACVUE360 (SERIAL# (B)(6)) UNIT AND PUT THE UNIT BACK TO SERVICE FOR PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263966 MACUVE360 ELECTROCARDIOGRAPH DPS \GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MACUVE360

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention MAC VU360 CAM, ADD ON, AHA W/LEADWIRES, BANANA ADAPTERS.