BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXDI-50RF

    MDR report key: 3190784 · Received June 20, 2013

    Report

    Report Number
    1000181430-2013-00111
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 21, 2013
    Manufacturer
    CANON, INC.
    Product Code
    OWB
    PMA / PMN Number
    K092439
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN-PROGRESS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED PER 21 CFR 803.56. THIS EVENT OCCURRED OUTSIDE USA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DEVICE WAS UNABLE TO TAKE IMAGE AND TO DO FLUOROSCOPY DURING EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280713 CXDI-50RF OWB CANON, INC. CXDI-50RF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK