BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, CONSOLE, BLADDERSCAN BVI 9400

    MDR report key: 2972517 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00037
    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
    PMA / PMN Number
    K071217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS PENDING ANALYSIS OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS READING INACCURATELY ON EVERY PATIENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69676 ASSY, CONSOLE, BLADDERSCAN BVI 9400 NONE IYO VERATHON INCORPORATED 0570-0190

    Patients

    Seq Age Sex Outcome Treatment
    1