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

Model Number TSC-301C

Device Problems No Display/Image (1183); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Insufficient Information (4580)

Event Date 10/19/2022

Event Type  malfunction  

Event Description

The ct scanner went down while performing a stroke series scan.The scanner froze during a pivotal moment in the series.The scanner then had to be rebooted which delayed the images being sent and read for the patient.Patient was moved to other room to quickly complete scans.There have been recent issues with the scanner malfunctioning during angio studies and volume studies.Additional events with freezing scanner include (but not reported to quality and so no additional information is available).Head and c-spine w/o.Pelvis w/o.Error message was "rtm error", recon of hip.Error message was "mpr not working."angio portion of dissection; head (scanner froze when pulling patient up on worklist; stroke (after perfusion, before carotid); trauma c/a/p with contrast; during qc, error in recon sequence.All of these failures require a reboot which leads to a delay in care and additional steps for the technical team.Canon has escalated this to both their national parts team and national service team.

• 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: 15804485
• MDR Text Key: 303723562
• Report Number: 15804485
• 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: 16060 DA
• Patient Sex: Female