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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TOSHIBA MEDICAL SYSTEMS CORPORATION VANTAGE TITAN 3T SCANNING SYSTEMS, MAGNETIC RESONANCE IMAGING (MRI)

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TOSHIBA MEDICAL SYSTEMS CORPORATION VANTAGE TITAN 3T SCANNING SYSTEMS, MAGNETIC RESONANCE IMAGING (MRI) Back to Search Results
Model Number VANTAGE TITAN 3T
Device Problems Device Emits Odor (1425); Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/03/2019
Event Type  malfunction  
Event Description
Patient was brought to mri for a scan of brain, cervical and thoracic spine. Scan was started at 0645. Brain and cervical spine were done, and thoracic exam was 50% complete when the scanner aborted during a sequence. The scanner was rebooted twice but would not scan. A strong electrical odor was noticed coming from the scanner bore area. The patient was removed from the scan room immediately and service was called.
 
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Brand NameVANTAGE TITAN 3T
Type of DeviceSCANNING SYSTEMS, MAGNETIC RESONANCE IMAGING (MRI)
Manufacturer (Section D)
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 michelle dr.
tustin CA 92780
MDR Report Key10275977
MDR Text Key198897123
Report Number10275977
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/10/2020,10/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVANTAGE TITAN 3T
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/10/2020
Device Age6 YR
Event Location No Information
Date Report to Manufacturer07/15/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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