BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI 9400

    MDR report key: 4173568 · Received September 19, 2014

    Report

    Report Number
    4173568
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    April 25, 2014
    Report Date
    August 22, 2014
    Manufacturer
    VERATHON
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    REGARDING BVI 9400 BLADDER SCANNER:PATIENT'S BLADDER WAS SCANNED TO ASSESS AMOUNT OF URINE IN BLADDER. THE SCANNER VALUE NOTED WAS 257 ML. THE ACTUAL AMOUNT OF URINE MEASURED VIA STRAIGHT CATHETERIZATION WAS 700 ML. THIS IS A SIGNIFICANT DIFFERENCE AND A COMMON PROBLEM WITH OUR CURRENT BLADDER SCANNER. THE INACCURACY OF THE SCANNER MAKES IT DIFFICULT FOR GOOD CLINICAL DECISION-MAKING TO OCCUR AND THUS COULD LEAD TO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582846 BVI 9400 SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO VERATHON BVI9400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * SUPPLIED FOR THIS REPORT, IT IS A RECURRING| NOT APPLICABLE. NO PATIENT INFORMATION WAS