MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION ALTAIRE MR SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number N/A

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, fujifilm healthcare americas corporation (formerly hitachi medical systems america, inc.) received a complaint regarding altaire mr system.The site reported brain images were flipped (right-left laterality).The original radiology report states the patient had an acute-early subacute infarct in the posterior left frontal white matter and suspect tiny old lacunar infarcts in the bilateral basal ganglia and left pons.The addendum states, an acute-early subacute infarct in the posterior right frontal white matter and suspect tiny old lacunar infarcts in the bilateral basal ganglia and right pons.This patient was treated with plavix, atorvastatin and aspirin.Treatment was not affected and would not have changed.There is no death associated with event.During a retrospective review, it was discovered that the manufacturer had assessed this event as ae leading to serious injury, therefore an importer mdr is being submitted.

• Brand Name: ALTAIRE MR SYSTEM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi; chiba-ken 277-0 704; JA 277-0704
• MDR Report Key: 13689527
• MDR Text Key: 290559842
• Report Number: 1528028-2022-00002
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/16/2020
• Device Age: 17 YR
• Event Location: Outpatient Diagnostic Facility
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Female