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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION OASIS MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
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FUJIFILM HEALTHCARE CORPORATION OASIS MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number SYS/MR/OASIS OPEN+VERTEX II
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/23/2024
Event Type  malfunction  
Event Description
On january 23rd 2024 fujifilm healthcare americas corporation was informed of an event involving sys/mr/oasis open+vertex ii.It was reported that after the customer ran her daily qa, she put her first patient on and ran the scanogram and got a white line and started to smell an electrical burning smell.The customer rebooted the machine and tried to scan again and keeps getting errors.There appear to be an issue with the gradient control power amplifier (gcpa) unit.There was no harm or injury to the patient.No additional information provided.
 
Manufacturer Narrative
Ref (b)(4).
 
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Brand Name
OASIS MRI SYSTEM
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 Key18685168
MDR Text Key335124816
Report Number1528028-2024-00003
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 01/25/2024,02/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSYS/MR/OASIS OPEN+VERTEX II
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? No
Distributor Facility Aware Date01/23/2024
Event Location Other
Date Report to Manufacturer01/25/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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