BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBESCAN

    MDR report key: 20587023 · Received November 1, 2024

    Report

    Report Number
    20587023
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 21, 2024
    Manufacturer
    MCUBE TECHNOLOGY CO., LTD.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHILE CONDUCTING PREVENTATIVE MAINTENANCE, THE EQUIPMENT FAILED. MANUFACTURER RESPONSE FOR BLADDER SCANNER, BIOCON-700 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631504 CUBESCAN TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX MCUBE TECHNOLOGY CO., LTD. BIOCON-700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose