BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGITAL RETINAL CAMERA CF-1

    MDR report key: 2945791 · Received January 28, 2013

    Report

    Report Number
    1000181430-2013-00010
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    May 24, 2010
    Manufacturer
    CANON, INC.
    Product Code
    HKI
    PMA / PMN Number
    K063717
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 SVC REP REPLACED THE SPLIT LINE MOTOR, AND ADJUSTED AND TESTED THE UNIT. HE FOUND THAT THE AC ADAPTER DOOR ON THE EOS WAS NOT FULLY CLOSED. HE COULD NOT VERIFY THE DARK VIEWING PROBLEM IN FLUORESCEIN MODE. THIS WAS AN ON-SITE REPAIR. THE UNIT TESTED OK AFTER THE REPAIR. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A DARK RING ON A LEFT EYE IMAGE. ALSO, IN FLUORESCEIN MODE, THE IMAGES GOT DARK AND THE CUSTOMER HAD TO REBOOT THE UNIT. THE CUSTOMER DID NOT MENTION THAT THEY HAD TO RE-INJECT THE PT WITH FLUORESCEIN OR RESCHEDULE THE PT. HOWEVER, THE INFO SUGGESTS THAT A REPEAT INJECTION MAY HAVE BEEN NECESSARY DURING THE EXAM DUE TO THE DELAY IN REBOOTING THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36881 DIGITAL RETINAL CAMERA CF-1 HKI CANON, INC. CF-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other