MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION AIRIS ELITE MR SYSTEM; MAGNETIC RESONANCE DIAGNOSTIC DEVICE.

Model Number N/A

Device Problem Device Handling Problem (3265)

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

Event Date 07/01/2020

Event Type  Injury  

Event Description

On july 06, 2020, fujifilm healthcare americas corporation (formerly hitachi medical systems america, inc.) received a complaint regarding airis elite mr system.This report is in regards to one (case 2) of 2 separate cases reported with confirmed misdiagnosis.The site reported image began flipping leading to the misdiagnosis as a result of head view being set to the top instead of bottom (manufacturer's recommendation).This patient received scan on (b)(6) 2020, and an amendment to the original report was required to correctly identify the laterality of a dermoid tumor in the brain, which was compared to a previous study done on the same patient.There is no information available with regards to the change in treatment plans or patient's condition due to misdiagnosis.There is no death or serious injury 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's mdr is being submitted.

• Brand Name: AIRIS ELITE MR 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 Key: 13689211
• MDR Text Key: 286743436
• Report Number: 1528028-2022-00015
• 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: 07/06/2020
• Device Age: 14 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: 60 YR