BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI 3000 DOME PROBE ASSY

    MDR report key: 2972537 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00052
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    VERATHNO MEDICAL
    Product Code
    EXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT WAS NOT CONFIRMED. THE SYSTEM OPERATED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS READING INACCURATELY. THIS ISSUE OCCURRED ON MULTIPLE PTS AND BY MULTIPLE USERS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69510 BVI 3000 DOME PROBE ASSY NONE EXQ VERATHNO MEDICAL 0570-0091

    Patients

    Seq Age Sex Outcome Treatment
    1