BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTSCAN IV DISPOSABLE

    MDR report key: 2689202 · Received July 17, 2012

    Report

    Report Number
    2689202
    Event Type
    Malfunction
    Date Received
    July 17, 2012
    Date of Event
    June 26, 2012
    Report Date
    July 17, 2012
    Manufacturer
    BIODEX
    Product Code
    IYT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    TECHNICIAN REPORTED THE VENT KIT FAILED TO NEBULIZE PROPERLY DURING PRE-EXAM TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTSCAN IV DISPOSABLE SYSTEM, REBREATHING, NEBULIZER IYT BIODEX 177-092 411516

    Patients

    Seq Age Sex Outcome Treatment
    1 *