BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, CONSOLE, BLADDERSCAN BVI 9400

    MDR report key: 2972623 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00027
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    VERATHON MEDICAL
    Product Code
    IYO
    PMA / PMN Number
    K071217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS PENDING ANALYSIS OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FROZE DUE TO A LOW BATTERY AND THE CUSTOMER DID NOT KNOW HOW TO CHANGE IT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69588 ASSY, CONSOLE, BLADDERSCAN BVI 9400 NONE IYO VERATHON MEDICAL 0570-0190

    Patients

    Seq Age Sex Outcome Treatment
    1