BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RETINAL CAMERA CF-1

    MDR report key: 2980288 · Received January 28, 2013

    Report

    Report Number
    1000181430-2013-00013
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    August 30, 2010
    Manufacturer
    CANON, INC.
    Product Code
    HKI
    PMA / PMN Number
    K063717
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED RETROACTIVELY AS A RESULT OF AN INTERNAL AUDIT OF COMPLAINT FILES CONDUCTED BY CANON HEALTHCARE SOLUTIONS USA. (B)(4). THE SERVICE REP ADJUSTED THE MECHANICAL ALIGNMENT AND CLEANED AND ADJUSTED THE ENTIRE UNIT. THE UNIT WAS FOUND TO BE IN GOOD WORKING ORDER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SPLIT LINES WERE SHOWING IN THE IMAGES. NO INFORMATION WAS PROVIDED REGARDING WHAT IMAGE TYPES (COLOR, RED-FREE, FLUORESCEIN ANGIOGRAPHY) WERE AFFECTED. THE CUSTOMER DID NOT STATE THAT THE FLUORESCEIN IMAGING WAS REPEATED. HOWEVER, IF THE PROBLEM OCCURRED DURING THE FLUORESCEIN IMAGING PORTION OF THE EXAM, THE TECH MAY HAVE RESCHEDULED THE EXAM. A RESCHEDULED EXAM WOULD HAVE INVOLVED A REPEAT INJECTION OF FLUORESCEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38407 DIGITAL RETINAL CAMERA CF-1 HKI CANON, INC. CF-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK