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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem Burning Sensation (2146)
Event Date 03/16/2022
Event Type  Injury  
Event Description
On march 16, 2022, fujifilm healthcare americas corporation received a complaint regarding the oasis xp 1. 2t open mri system. It was reported that the patient felt very hot and broke out in a sweat during a pelvic exam prior to being given contrast. The sensation dissipated within 5 minutes of the scan ending. It is recommended to align the scans but pause in between each scan for reconstruction to take place. This will allow the patient's body to cool between sequences. Instead, the scans were reportedly performed back to back without any pause/breaks. There was no report of any burns or serious injury to the patient. There is no death associated with the event. This issue was initially identified as a non-reportable event. During a retrospective review, it was determined that this complaint should be reported 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 Key14382074
MDR Text Key293716692
Report Number1528028-2022-00039
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 05/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Date04/14/2022
Event Location Outpatient Diagnostic Facility
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/12/2022 Patient Sequence Number: 1
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