MAUDE Adverse Event Report: CANON MEDICAL SYSTEM, USA, INC. CANON AQUILION ONE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number TSC-301C

Device Problems Display or Visual Feedback Problem (1184); Loss of Data (2903)

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

Event Date 11/02/2022

Event Type  malfunction  

Event Description

A ct angiogram (cta) of the thoracoabdominal aorta was being performed and during the volume of the heart, the scanner froze.Ultimately, cardiac images were lost.Up to this point, when they have had issues with the scanner freezing during the angio or volume phase of various studies, they have been able to salvage the study.Images were lost in this case.(no patient injury.) escalated to service manager at canon.

• Brand Name: CANON AQUILION ONE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): CANON MEDICAL SYSTEM, USA, INC.; 2441 michelle dr.; tustin CA 92780
• MDR Report Key: 15804417
• MDR Text Key: 303726607
• Report Number: 15804417
• 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: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: TSC-301C
• 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: 11/08/2022
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Sex: Male