Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION ALTAIRE MRI SYSTEM; MAGNETIC RESONANCE DIAGNOSTIC DEVICE.
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FUJIFILM HEALTHCARE CORPORATION ALTAIRE MRI SYSTEM; MAGNETIC RESONANCE DIAGNOSTIC DEVICE. Back to Search Results
Model Number N/A
Device Problem Device Emits Odor (1425)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2022
Event Type  malfunction  
Event Description
On june 08, 2022 fujifilm healthcare americas corporation received a complaint regarding altaire mri system.The site reported smelling a burning smell while scanning a patient.The tech safely removed the patient from the scanner.The scan was 85% completed, though it was later reported that the doctor collected enough images and does not anticipate bringing the patient back for more scanning.There is no death or serious injury associated with event.As such, this is being submitted in an abundance of caution.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALTAIRE MRI SYSTEM
Type of Device
MAGNETIC RESONANCE DIAGNOSTIC DEVICE.
Manufacturer (Section D)
FUJIFILM HEALTHCARE CORPORATION
2-1 shintoyofuta
kashiwa-shi, chiba-ken 277-0 704
JA  277-0704
MDR Report Key14841433
MDR Text Key295253677
Report Number1528028-2022-00049
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 06/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
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 Date06/08/2022
Device Age20 YR
Event Location Outpatient Diagnostic Facility
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-