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

Model Number TSC-301C

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 10/31/2022

Event Type  malfunction  

Event Description

Young trauma patient (hit head on ground and vomiting with headaches) to have head scan without contrast and during recon of volume head, the scanner froze.Team member had to restart the scanner and this delayed the images being read in a timely manner.No injury to patient.

• 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: 15804445
• MDR Text Key: 303719116
• Report Number: 15804445
• 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 Operator: Other
• 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: 2920 DA
• Patient Sex: Female