BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2240666 · Received September 2, 2011

    Report

    Report Number
    2240666
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    March 11, 2011
    Report Date
    September 2, 2011
    Manufacturer
    *
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CAMERA LENSES DID NOT HAVE CLEAR VIEW.======================MANUFACTURER RESPONSE FOR CAMERA LENS MRI0, (BRAND NOT PROVIDED) (PER SITE REPORTER)======================RETURNED FOR REPAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CAMERA LENS MRI0 KOG * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *