MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number INFX-8000C

Device Problem Environmental Particulates (2930)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

X-ray tube information as followed: x-ray tube device manufacturer canon electron tubes & devices model: dsrx-t7345gfs: serial: (b)(6).

Event Description

In a japan hospital on (b)(6) 2024 the customer received an (error x7e: x7e is an error that means the starter is not working properly) when the system was powered on after two hours.Service engineer visited on the same day and replaced the starter, but the problem remained.The next day service engineer visited the hospital with the replacement and when the service engineer opened the tube cover he discovered that the starter cable connector was burnt out.Service engineer replaced the x-ray tube including starter cable and the system operated normally.There were no health hazards to patients or operators.

• Brand Name: CANON
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer (Section G): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer Contact: paul biggins ; 2441 michelle drive; tustin,, CA 92780 ; 7146697808
• MDR Report Key: 18682387
• MDR Text Key: 336298430
• Report Number: 2020563-2024-00002
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: INFX-8000C
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1