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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION SYS/MR/ECHELON XL 1.5T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
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FUJIFILM HEALTHCARE CORPORATION SYS/MR/ECHELON XL 1.5T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number SYS/MR/ECHELON XL 1.5T
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2024
Event Type  malfunction  
Event Description
On (b)(6) fujifilm healthcare americas corporation was informed of an event involving sys/mr/echelon xl 1.5t it was reported that the x gradient lead burned open at the rear of the gantry.It was later confirmed that there was a patient on the table when the gradient lead burned open.Tech got the patient off the table without incident.The imaging was not completed on this scanner but the tech had to move this exam to the other mri unit.There was no harm or injury to the patient.
 
Manufacturer Narrative
Ref comp# (b)(4).
 
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Brand Name
SYS/MR/ECHELON XL 1.5T
Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
FUJIFILM HEALTHCARE CORPORATION
2-1 shintoyofuta
kashiwa-shi, chiba-ken 27708 04,
JA  2770804,
MDR Report Key18923996
MDR Text Key337904224
Report Number1528028-2024-00008
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSYS/MR/ECHELON XL 1.5T
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/18/2024
Distributor Facility Aware Date02/20/2024
Event Location Hospital
Date Report to Manufacturer02/20/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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