BEUDAMED
    FDA Adverse Event Summary report: N

    CANON CXDI-DMW PS2 VERSION 4.5 SOFTWARE

    MDR report key: 2366245 · Received December 6, 2011

    Report

    Report Number
    1000181430-2011-00003
    Date Received
    December 6, 2011
    Date of Event
    March 17, 2010
    Report Date
    December 6, 2011
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K081648
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE RELEASED NEW SOFTWARE CXDI-DMW PS2 VER.4.53 AND UPGRADED TO IT FOR THE SITES WHERE MULTI ACCESSION FUNCTION ON CXDI-DMW PS2 VER.4.50 TO 4.52 IS USED.

    Description of Event or Problem · 1

    ON (B)(4) 2010, CANON U.S.A, INC. (B)(4), RECEIVED A CALL FROM THEIR DEALER REGARDING A CXDI-60G SENSOR PANEL WITH AN ISSUE OF "UNEXPECTED STUDY INFORMATION." A PT IDENTIFIED ABOVE HAD IMAGES WHICH WAS FOR OTHER PT'S EXAMINATIONS. THERE IS A POTENTIAL OF MISFILING ONE PT'S IMAGES FOR A DIFFERENT PT'S IMAGES WHEN DATA IS SENT THROUGH PACS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANON CXDI-DMW PS2 VERSION 4.5 SOFTWARE DMW PS2 MQB CANON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Other