MAUDE Adverse Event Report: CANON, INC CXDI-701CW

Model Number CXDI-701CW

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 12/05/2013

Event Type  malfunction  

Event Description

The customer reported system displayed error message and be unable to operate normally as below.During the tech took images 2 exam by mobile x-ray, 1st image could be captured w/o problem.However, after moving to another protocol for 2nd image and exposure was performed, the image could not be captured.A cursor could be moved, on the other hand, any button on gui were unable to press.Therefore, they forced-quit an application.Pt had to be image retaken, it is resulting in excessive radiation exposure.

Manufacturer Narrative

Gender info was not provided.Investigation is still in-progress.If additional info is received, a supplemental report will be submitted per 21 cfr 803.56.This event occurred outside usa.(b)(4).

• Brand Name: CXDI-701CW
• Manufacturer (Section D): CANON, INC; tokyo 146- 8501; JA 146-8501
• Manufacturer Contact: shinji mori, mgr ; 30-2 shimomaruko, 3-chome; ohta-ku; tokyo 14685-01 ; JA 1468501 ; 37582111
• MDR Report Key: 3697405
• MDR Text Key: 4252632
• Report Number: 1000181430-2014-00002
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131106
• 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: 12/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CXDI-701CW
• Device Catalogue Number: 8559B001AA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2013
• Date Device Manufactured: 05/01/2013
• 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