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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION OASIS XP 1.2T OPEN MRI SYSTEM MAGNETIC RESONANCE DIAGNOSTIC DEVICE

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FUJIFILM HEALTHCARE CORPORATION OASIS XP 1.2T OPEN MRI SYSTEM MAGNETIC RESONANCE DIAGNOSTIC DEVICE Back to Search Results
Model Number N/A
Device Problem Temperature Problem (3022)
Patient Problem Burning Sensation (2146)
Event Date 05/19/2022
Event Type  malfunction  
Event Description
On may 19, 2022, fujifilm healthcare americas corporation received a complaint regarding the oasis xp 1. 2t open mri system. It was reported that the patient felt a burning sensation while undergoing a scan of the lumbar spine. The patient did not complain of any burning sensation during the first portion of the scan, but before being injected with contrast, the patient stated she felt a burning sensation and warmness on her back. Upon examination, the radiologist observed that the affected area was warm to the touch. However, there was no report of visible blistering/redness and burns or serious injury to the patient. There is no death associated with the event. As such, this report is being submitted in an abundance of caution.
 
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Brand NameOASIS XP 1.2T OPEN MRI SYSTEM
Type of DeviceMAGNETIC RESONANCE DIAGNOSTIC DEVICE
Manufacturer (Section D)
FUJIFILM HEALTHCARE CORPORATION
2-1 shintoyofuta
kashiwa-shi, chiba-ken 277-0 804
JA 277-0804
MDR Report Key14551555
MDR Text Key293086063
Report Number1528028-2022-00041
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 05/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date05/19/2022
Device Age12 YR
Event Location Outpatient Diagnostic Facility
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

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