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

Model Number	CXDI-401C COMPACT
Medical Device Problem Code	Misassembly During Maintenance/Repair (4054)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional 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 #: mw5090482.
Event or Problem 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
• Common Device Name: X-RAY DIGITAL RADIOGRAPHY
• Manufacturer (Section D): CANON, INC.; 9-1, imaikami-cho, nakahara-ku; kawasaki, JP 21 1-85; JA JP 211-850
• MDR Report Key: 9508740
• Report Number: 1000181430-2019-00001
• Device Sequence Number: 2133736
• Product Code: MQB
• UDI-Device Identifier: 04549292049695
• UDI-Public: 04549292049695
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/27/2019

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
• Operator of Device: Health Professional
• Device Model Number: CXDI-401C COMPACT
• Device Catalogue Number: 4995B003AE
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR