MAUDE Adverse Event Report: CANON / TOSHIBA / CANON MEDICAL SYSTEMS CORPORATION ACQUILION ONE; SYSTEM, X-RAY TOMOGRAPHY COMPUTED

Model Number ONE-VISION-640-SERIES 000

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Chemical Exposure (2570)

Event Date 11/15/2018

Event Type  malfunction  

Event Description

During the contrast phase of a ct - angiogram of the heart, the scanner displayed an error message resulting in the abortion of the scan phase of the examination.This error resulted in the pt receiving 70cc's of omnipaque 350 iv contrast without a diagnostic ct scan.This is the second such error which has prevented the scanning of a pt after they had received medication for contrast enhancement.A repeat cta was performed after the ct scanner was restarted and the pt had to receive double the amount of necessary iv contrast.

• Brand Name: ACQUILION ONE
• Type of Device: SYSTEM, X-RAY TOMOGRAPHY COMPUTED
• Manufacturer (Section D): CANON / TOSHIBA / CANON MEDICAL SYSTEMS CORPORATION; JA
• MDR Report Key: 8155090
• MDR Text Key: 130214810
• Report Number: MW5082036
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONE-VISION-640-SERIES 000
• Device Catalogue Number: TSX-301C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other