MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION AQUILION ONE PRISM; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number PRISM CT

Device Problems Poor Quality Image (1408); Arcing (2583)

Patient Problem Insufficient Information (4580)

Event Date 09/23/2020

Event Type  malfunction  

Event Description

Scanner malfunctioned and caused a tube arc on the scan.Image quality was significantly decreased and the patient had to be rescanned and double radiated.Many tube arcs have occurred on the scanner and continued to occur.

• Brand Name: AQUILION ONE PRISM
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 2441 michelle dr; tustin CA 92780
• MDR Report Key: 10733385
• MDR Text Key: 213011191
• Report Number: 10733385
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRISM CT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1