MAUDE Adverse Event Report: CANON, INC CXDI-70CW

Model Number CXDI-70CW

Device Problem Loss of Data (2903)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 10/25/2013

Event Type  malfunction  

Manufacturer Narrative

Gender info was not provided by reporter.The date for evaluation was collected and provided to mfr.It was found that exclusive control for multiple threads that are generated when 1st preview image is operated was insufficient.Since specified object was referred by those threads, they may refer to null depending on the operation.Due to this exclusive control, failure to catch the exception caused system down before the process for image capture is completed.This event was occurred outside usa.(b)(4).

Event Description

The report of user facility stated as following:when an pelvis image was operated to rotate after exam of chest and pelvis, display become to be black and 3 command buttons were appeared.After restarting, the tech looked for the images taken previously at folder for saving image, only pelvis image was disappeared.The image was retaken, resulting in additional radiation exposure.

• Brand Name: CXDI-70CW
• Manufacturer (Section D): CANON, INC; tokyo 146- 8501; JA 146-8501
• Manufacturer Contact: shinji mori, mgr ; 30-2 shimomaruko, 3-chome; ohta-ku; tokyo 146-8-501 ; JA 146-8501 ; 37588542
• MDR Report Key: 3770302
• MDR Text Key: 15954819
• Report Number: 1000181430-2014-00004
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• PMA/PMN Number: K1202012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/07/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CXDI-70CW
• Device Catalogue Number: 4066B002AA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2014
• Initial Date FDA Received: 01/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CONTROL SOFTWARE NE V1.30.0