BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADDERSCAN BVI 3000

    MDR report key: 1731685 · Received June 1, 2010

    Report

    Report Number
    1731685
    Event Type
    Malfunction
    Date Received
    June 1, 2010
    Date of Event
    May 26, 2010
    Report Date
    June 1, 2010
    Manufacturer
    VERATHON INC.
    Product Code
    EXQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT HAS A DIAGNOSIS OF BILATERAL HYDRONEPHROSIS. THE DR ORDERED A NON-INVASIVE BLADDER SCAN TO DETERMINE IF THERE WAS ANY RESIDUAL URINE IN THE BLADDER. THE NURSE UTILIZED THE BLADDER SCANNER WHICH DID NOT DETECT ANY URINE IN THE BLADDER. THE PROBE HAD A CRACK IN IT. THE ISSUE IS THAT WHEN THE BLADDER SCANNER DID ITS "SELF TEST" IT DID NOT DETECT A DEFECTIVE PROBE. A SECOND SCANNER WAS OBTAINED AND DETECTED THE URINE IN THE BLADDER.THERE WAS A DELAY IN DETERMINING THE VOLUME OF URINARY RETENTION IN THE PT WHO HAD HYDRONEPHROSIS AND A URINARY TRACT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADDERSCAN BVI 3000 CYSTOMETER, BLADDER SCAN EXQ VERATHON INC. BVI 3000 400370024

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR