BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RETINAL CAMERA CF-1

    MDR report key: 2980383 · Received January 28, 2013

    Report

    Report Number
    1000181430-2013-00018
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    September 26, 2011
    Manufacturer
    CANON INC.
    Product Code
    HKI
    PMA / PMN Number
    K063717
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    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. GENDER INFORMATION WAS NOT PROVIDED. (B)(4). THE SERVICE REPRESENTATIVE REPLACED THE SPLIT PRISM MOTOR. HE ALIGNED THE SPLIT PRISM AND ADJUSTED TO OD POSITION. HE CLEANED THE OPTIC AND LUBRICATED THE QUICK RELEASE MIRROR. THE SYSTEM WAS THEN TESTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A SPLIT LINE SHADOW 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 TECHNICIAN MAY HAVE RESCHEDULED THE EXAM. A RESCHEDULED EXAM WOULD HAVE INVOLVE A REPEAT INJECTION OF FLUORESCEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38224 DIGITAL RETINAL CAMERA CF-1 HKI CANON INC. CF-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK