BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI 3000 DOME PROBE ASSY

    MDR report key: 2961097 · Received February 8, 2013

    Report

    Report Number
    3022472-2013-00016
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    VERATHON MEDICAL
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS NOT CONFIRMED. THE PROBE WAS TESTED ON A BLADDER PHANTOM; ALL SCANS WERE WITHIN PUBLISHED RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE PROVIDED INACCURATE MEASUREMENTS. THE DEVICE VALUES SHOWED 275 ML BUT THE PT VOIDED 50 ML. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54152 BVI 3000 DOME PROBE ASSY NONE IYO VERATHON MEDICAL 0570-0091

    Patients

    Seq Age Sex Outcome Treatment
    1