BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, CONSOLE, BLADDERSCAN BVI 9400

    MDR report key: 2972521 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00041
    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
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUES COULD NOT BE CONFIRMED. THE SYSTEM WAS CLEANED AND TESTED. THE SYSTEM OPERATED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT SCANNING AT ALL. IT WAS PLACED ON THE FLOOR AND HAD ONLY PERFORMED 15 SCANS. THERE WAS NO RESPONSE WHEN IT WAS TURNED ON OR OFF. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69544 ASSY, CONSOLE, BLADDERSCAN BVI 9400 NONE IYO VERATHON INCORPORATED 0570-0190

    Patients

    Seq Age Sex Outcome Treatment
    1