BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI 3000 CONTROL BOX

    MDR report key: 2972641 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00024
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    VERATHON MEDICAL
    Product Code
    EXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS PENDING ANALYSIS OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE READ ALL ZEROS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69694 BVI 3000 CONTROL BOX NONE EXQ VERATHON MEDICAL 0570-0090

    Patients

    Seq Age Sex Outcome Treatment
    1