MAUDE Adverse Event Report: CANON, INC. DIGITAL RADIOGRAPHY CXDI; X-RAY DIGITAL RADIOGRAPHY

Model Number CXDI-401C COMPACT

Device Problem Misassembly During Maintenance/Repair (4054)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

This event happened when the service person updated the control software of the x-ray detectors (cxdi-401c compact/701c wireless).The service person did not confirm whether the captured image could be output to pacs system normally and installation error was not noticed, as a result he handed it over to the customer with incorrect installation.From the above, the cause is determined as an installation error of the service person, and the work procedure will be notified to the service person once again.This event will not cause any serious health hazards to the patient.In addition to cxdi-401c compact other related device information is described as below.Additional device information: model number #: cxdi-701c wireless; catalog number #: 8559b003af; serial number #: (b)(4); udi number #: (b)(4); pma/510(k) number #: k131106.Manufacturer cross-reference #:mw5090483.

Event Description

After updating the control software for x-ray detectors (cxdi-401c compact/701c wireless), the captured image could not be send to pacs system, and then eventually the image disappeared.

• Brand Name: DIGITAL RADIOGRAPHY CXDI
• Type of Device: X-RAY DIGITAL RADIOGRAPHY
• Manufacturer (Section D): CANON, INC.; 9-1, imaikami-cho, nakahara-ku; kawasaki, JP 21 1-85; JA JP 211-850
• Manufacturer Contact: yasuhiko minagawa ; 9-1, imaikami-cho, nakahara-ku; kawasaki, kanagawa JP 21-1-85 ; JA JP 211-850
• MDR Report Key: 9508737
• MDR Text Key: 177157908
• Report Number: 1000181430-2019-00002
• Device Sequence Number: 1
• Product Code: MQB
• UDI-Device Identifier: 04549292049695
• UDI-Public: 04549292049695
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CXDI-401C COMPACT
• Device Catalogue Number: 4995B003AE
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 74