BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJI CR

    MDR report key: 1625620 · Received March 3, 2010

    Report

    Report Number
    1625620
    Event Type
    Malfunction
    Date Received
    March 3, 2010
    Date of Event
    February 16, 2010
    Report Date
    March 3, 2010
    Manufacturer
    FUJIFILM MEDICAL SYSTEM USA, INC.
    Product Code
    MQB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US

    Narratives

    Description of Event or Problem · 1

    AN X-RAY WAS TAKEN THAT WAS DOUBLE EXPOSED AND SHOULD HAVE BEEN REPEATED. THE AUTOCROPPING DID NOT DETECT A PREVIOUS EXPOSURE ON THE IMAGE PLATE AND CROPPED TO THE SECOND EXPOSURE. IN THE FUTURE, THE AUTOCROPPING FEATURE WILL BE DISENGAGED.THIS ISSUE WAS REVEALED WHEN, DURING A QA REVIEW PROCESS FOR COLLIMATION, AN IMAGE WAS PULLED UP FROM THE FUJI CR READER AND THE CROPPING REMOVED. UPON REMOVING THE CROPPED AREA IT WAS NOTICED THAT THERE WAS A DOUBLED EXPOSURE ON THE IMAGE PLATE. THE CR READER'S AUTO CROPPING HAD CROPPED THE SECOND EXPOSURE AND ELIMINATED THE AREA WHERE THE TECHNOLOGIST WOULD NOTICE THE VARIANCE. THE IMAGE WAS REPEATED IN THIS INSTANCE WITH NO KNOWN NEGATIVE OUT COMES. AFTER NOTICING THIS ISSUE A TEST WAS PERFORMED, RESULTING IN THE SAME OUTCOME. AUTO-CROPPING WAS REQUESTED TO BE TURNED OFF, SO THAT THIS ISSUE WOULD NOT OCCUR AGAIN. THE TECHNOLOGIST WILL STILL BE ABLE TO MANUALLY CROP THE IMAGES; HOWEVER, THEY CAN REVIEW THE ENTIRE PLATE TO SEE IF THERE HAS BEEN A DOUBLE EXPOSURE AND REPEAT THE IMAGE. THIS WILL PREVENT MISSED DIAGNOSIS THAT COULD POSSIBLY OCCUR UNINTENTIONALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUJI CR CR READER MQB FUJIFILM MEDICAL SYSTEM USA, INC. CR-IR 362 *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DA