BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1990777 · Received February 1, 2011

    Report

    Report Number
    1990777
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 1, 2011
    Manufacturer
    VERATHON INCORPORATED
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD ORDERS TO BE DISCHARGED AFTER SHE WAS ABLE TO PASS HER VOIDING TRIAL. THROUGHOUT THE DAY SHE HAD HIGH POST VOID RESIDUALS, ALTHOUGH THEY WERE IMPROVING WITH SUBSEQUENT VOIDS. THE PATIENT WAS VERY FRUSTRATED THAT THE PVR (POST VOID RESIDUAL) AMOUNTS WERE STILL NOT LOW ENOUGH (169MLS) FOR DISCHARGE AND DID NOT WANT TO GO HOME WITH A FOLEY CATHETER. I DISCUSSED THE MATTER WITH THE DOCTOR AND HE SAID THAT SHE WAS VOIDING LARGE QUANTITIES (800MLS) AND HE SAID THAT SHE COULD GO HOME IF SHE AGREED TO VOID EVERY HOUR AND SET AN ALARM TO GET UP TO VOID AT MIDNIGHT. WHEN I RETURNED TO THE PATIENT ROOM WITH THE DISCHARGE PAPERWORK SHE STATED THAT SHE HAD VOIDED ANOTHER 100 MLS AND WANTED ME TO SCAN HER BLADDER AGAIN. AT THIS POINT SHE SHOULD HAVE LESS THAN 100 MLS IN HER BLADDER BECAUSE A FEW MINUTES BEFORE HER PVR WAS 169. THE PATIENT STATED THAT SHE FELT LIKE SHE HAD REALLY EMPTIED HER BLADDER THIS TIME. I SCANNED HER BLADDER AGAIN AND THE READINGS WERE BETWEEN 270 AND 360. THE PATIENT STATED THAT IF HER RESIDUALS WERE REALLY THAT HIGH WHEN SHE FELT LIKE SHE WAS EMPTY, THAN IT WOULD BE BEST TO INSERT A FOLEY CATHETER. I INSERTED A FOLEY CATHETER INTO HER BLADDER (WITH GOOD VISUALIZATION) AND HER BLADDER WAS COMPLETELY EMPTY. IT IS UNLIKELY THAT A PATIENT WOULD HAVE A PVR OF 300 RANGE AFTER VOIDING 900 MLS OF URINE AND IMPOSSIBLE THAT A BLADDER WITH 300 MLS OF URINE WOULD RESULT IN A CATH AMOUNT OF ZERO. I BELIEVE THIS PROBLEM WAS CAUSED BY EQUIPMENT ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ULTRASOUND, DIAGNOSTIC, BLADDER SCANNER IYO VERATHON INCORPORATED UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR