BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI 3000 DOME PROBE ASSY

    MDR report key: 2961113 · Received February 8, 2013

    Report

    Report Number
    3022472-2013-00017
    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
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS PENDING ANALYSIS OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROBE WAS NOT PROVIDING READINGS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54933 BVI 3000 DOME PROBE ASSY NONE IYO VERATHON MEDICAL 0570-0091

    Patients

    Seq Age Sex Outcome Treatment
    1