MAUDE Adverse Event Report: HITACHI LTD, HEALTHCARE BUSINESS UNIT AIRIS ELITE MR SYSTEM; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number H755

Device Problem Use of Device Problem (1670)

Patient Problems Misdiagnosis (2159); Patient Problem/Medical Problem (2688)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

Hitachi applications were reviewing images for h755, airis elite when they noticed that the head view setting was set to "top" rather than hha's recommended "bottom".This setting is available to the customer and can be changed by the site to reflect their preference in scanning positions.When the scanner is set to "top", the images are flipped laterally.However, the images are correctly labeled (with left, right, anterior, and posterior labels).Applications reached out to the site and assisted in resetting the head view setting to "bottom" and also asked the site to review previous scans or radiology reports for errors.A service engineer was also dispatched to the site to evaluate the system.The site reviewed scans that were completed between march and july and determined 2 patients were misdiagnosed due to the radiologist incorrectly interpreting the scans.The site amended 2 patients' radiology reports.The site does not have any treatment information for either patients.Patient 1 is (b)(6) years old, the original radiology report states that this patient has a complete opacification of the left maxillary sinus.There is opacification of ethmoid air cells bilaterally, worse on the left.The addendum states, the opacified maxillary sinus is the right maxillary sinus, not the left.Patient 2 is (b)(6) years old, the original radiology report states that this patient has a 3.2cm mass at the left cerebellopontine angle resulting in mild mass effect on the contiguous cerebellum and pons.The right cerebellopontine angle appears normal.The addendum states, the recurrent dermoid tumor is on the right, not on the left.There is no abnormality at the left cerebellopontine angle.The site had several technologists on staff between march, 2020 and july, 2020.Hitachi also dispatched service to the site several times during this time period for troubleshooting and preventative maintenance.It is possible that either the site's staff or a service engineer changed the head view setting.The cause cannot be definitely traced to either party.

Event Description

On july 6, 2020 hitachi received report of two misdiagnosis from a site.The site was using the airis elite (h755) with head view set to top rather than hha's recommended bottom.

• Brand Name: AIRIS ELITE MR SYSTEM
• Type of Device: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): HITACHI LTD, HEALTHCARE BUSINESS UNIT; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 704; JA 277-0704
• Manufacturer (Section G): HITACHI LTD., HEALTHCARE BUSINESS UNIT; 2-1 shinotoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer Contact: jessie san ; 1959 summit commerce park; twinsburg, oh ; 4251313356
• MDR Report Key: 10368986
• MDR Text Key: 202620260
• Report Number: 8030405-2020-00003
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other