BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI 3000 DOME PROBE ASSY

    MDR report key: 2972460 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00066
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP REPLACED THE CRACKED PROBE DOME ASSEMBLY (PROBE WAS LEAKING). THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROBE WAS LEAKING OIL. THE LEAKING PROBE WAS FOUND BY A VERATHON SERVICE TECH, AND NOT REPORTED BY THE CUSTOMER. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69440 BVI 3000 DOME PROBE ASSY NONE IYO VERATHON INCORPORATED 0570-0091

    Patients

    Seq Age Sex Outcome Treatment
    1