BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI 3000 DOME PROBE ASSY

    MDR report key: 2972458 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00065
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    VERATHON INCORPORATED
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. THE SERVICE REP REALIGNED THE PROBE. THEY ALSO REPAIRED A CRACKED LENS (COSMETIC DAMAGE) AND MEASURED 135/135ML ON A 133ML PHANTOM. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS READING HALF OF WHAT PATIENTS ARE VOIDING. THIS HAPPENED TWICE BUT THE CUSTOMER WASN¿T SURE IF THIS WAS WITH MORE THAN ONE END USER. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69668 BVI 3000 DOME PROBE ASSY NONE IYO VERATHON INCORPORATED 0570-0091

    Patients

    Seq Age Sex Outcome Treatment
    1