BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGITAL RETINAL CAMERA CF-1

    MDR report key: 2945789 · Received January 28, 2013

    Report

    Report Number
    1000181430-2013-00014
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    September 28, 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
    CA, 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. (B)(4). THE COMPLAINT WAS HANDLED THROUGH PHONE SUPPORT. THE SVC ENGINEER SUGGESTED REPLACEMENT OF THE POWER SUPPLY. THE HOSPITAL SVC SAID THEY WOULD REPLACE THE POWER SUPPLY AND CALL BACK IF NEEDED.(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CAMERA STOPPED DURING THE FLUORESCEIN ANGIOGRAPHY PORTION OF THE EXAM. THE CUSTOMER DID NOT MENTION THAT THEY HAD TO RE-INJECT THE PT WITH FLUORESCEIN OR RESCHEDULE THE PT EXAM. HOWEVER, THE INFO SUGGESTS THAT A REPEAT INJECTION MAY HAVE BEEN NECESSARY DURING THE EXAM OR A RESCHEDULED EXAM DUE TO THE CAMERA STOPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38019 DIGITAL RETINAL CAMERA CF-1 HKI CANON, INC. CF-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other