BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USCAN

    MDR report key: 21883126 · Received April 22, 2025

    Report

    Report Number
    MW5169406
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    April 16, 2025
    Report Date
    April 17, 2025
    Manufacturer
    SIGNOSTICS /ECHONOUS, INC.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SIGNOSTICS BLADDER SCANNERS - USCAN SYSTEM HAS BEEN UNRELIABLE TO OBTAIN BLADDER VOLUME MEASURE. TRANSDUCER /PROBE "FANNING" PROCESS FOR SCANNING IS REPORTEDLY TROUBLESOME AND RESULTS IN ACQUISITION FAILURES, LACK OF ACCURACY IN VOLUME MEASUREMENTS AS WELL AS DIFFICULT AND TIME-CONSUMING MEASUREMENT CORRECTIONS WHICH OFTEN DO NOT OFFER A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272258 USCAN SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO SIGNOSTICS /ECHONOUS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown