MAUDE Adverse Event Report: CANON, INC. CXDI-60C

Model Number CXDI-60C

Device Problem Image Display Error/Artifact (1304)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 12/06/2013

Event Type  malfunction  

Event Description

The customer reported the image was separated into sections and the image had to be repeated.

Manufacturer Narrative

Gender information was not provided.(b)(4): investigation is still in-progress.If additional information is received, a supplemental report will be submitted per 21 cfr 803.56.(b)(4).

• Brand Name: CXDI-60C
• Manufacturer (Section D): CANON, INC.; tokyo 146- 8501; JA 146-8501
• Manufacturer Contact: shinji mori, manager ; 30-2 shimomaruko, 3-chome; ohta-ku, tokyo 146-8-501 ; JA 146-8501 ; 37578542
• MDR Report Key: 3647097
• MDR Text Key: 21728465
• Report Number: 1000181430-2014-00001
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091545
• 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: 12/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CXDI-60C
• Device Catalogue Number: 3931B002AA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2013
• Date Device Manufactured: 11/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 DA