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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CANON MEDICAL SYSTEM, USA, INC. CANON AQUILION PRIME; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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CANON MEDICAL SYSTEM, USA, INC. CANON AQUILION PRIME; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number CGS-72A/2B
Device Problem No Display/Image (1183)
Patient Problem Emotional Changes (1831)
Event Date 06/15/2021
Event Type  malfunction  
Event Description
Scanner would not build images after scanning the patient, so images were not visible at all.This resulted in a three hour patient care delay on a trauma protocol while this was worked on.Equipment has had problems like this before which were looked into by biomed last week, but are clearly unresolved.Patient was very angry per provider.Wait time was greater than 3 hours for results.Patient discharged home with follow up with neurosurgery.Sent htm for follow up.Canon was notified by ct manager today.Radiology rsa team added to discussion.Update from radiology: event reviewed, service and ct technologists were unable to duplicate slowness.Multiple tests were run.
 
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Brand Name
CANON AQUILION PRIME
Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
CANON MEDICAL SYSTEM, USA, INC.
2441 michelle dr
tustin CA 92780
MDR Report Key12040163
MDR Text Key257474466
Report Number12040163
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCGS-72A/2B
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/17/2021
Event Location Hospital
Date Report to Manufacturer06/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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