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

Model Number PRISM CT

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

During the middle of the scan, it aborted.Tried to rescan the part that was not yet imaged and it aborted right away.We attempted to scan again multiple times but every time we tried, it aborted again.We eventually got it to scan the rest of the patient.Part for scanner should be coming in but we do not know what time it will be repaired.

• 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: 10733573
• MDR Text Key: 213011350
• Report Number: 10733573
• 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

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1