BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RETINAL CAMERA CX-1

    MDR report key: 2980345 · Received January 28, 2013

    Report

    Report Number
    1000181430-2013-00029
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    August 15, 2012
    Manufacturer
    CANON INC.
    Product Code
    NFJ
    PMA / PMN Number
    K092565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 DEALER SERVICE REPRESENTATIVE ADJUSTED THE OPTICAL SENSOR IN THE SPLIT LINE ASSEMBLY. THIS RESOLVED THE ISSUE AND THERE HAVE BEEN NO MORE PROBLEMS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE GETTING A SHADOW OF THE SPLIT BAR ASSEMBLY (IN THE IMAGE), AS A RESULT OF A SPLIT DRIVE UNIT FAILURE. 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 INVOLVED A REPEAT INJECTION OF FLUORESCEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37305 DIGITAL RETINAL CAMERA CX-1 NFJ CANON INC. CX-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK