BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI 9400

    MDR report key: 4146509 · Received September 19, 2014

    Report

    Report Number
    4146509
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    April 21, 2014
    Report Date
    August 19, 2014
    Manufacturer
    VERATHON INC.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD UROLOGY PROCEDURE AND WAS UNABLE TO VOID IN PACU. BLADDER SCAN WAS DONE AND THE READING WAS 480 ML. PATIENT WAS ISC'D (INTERNAL STRAIGHT CATH) FOR 800 ML URINE IN BLADDER. THIS IS A SIGNIFICANT DIFFERENCE AND THERE IS POTENTIAL FOR PATIENT HARM WHEN THE DEVICE IS SO INACCURATE.FEEDBACK FROM CLINICAL USER, CONCERNS ABOUT "...BASING CLINICAL DECISIONS ON THE VALUES GIVEN BY THE SCANNER (I.E., WHETHER OR NOT TO CATHETERIZE A PATIENT BASED ON THE VOLUME OF URINE IN THE BLADDER, AS INDICATED BY THE SCANNER)."MANUFACTURER RESPONSE FOR BLADDER SCANNER, BVI 9400 BLADDER SCANNER (PER SITE REPORTER).======================CALIBRATION WAS CHECKED AND FOUND WITHIN PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582871 BVI 9400 SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO VERATHON INC. BVI 9400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR