MAUDE Adverse Event Report: HITACHI LTD, HEALTHCARE BUSINESS UNIT OASIS; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number	OASIS
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Issue (2379); Human Factors Issue (2948)
Health Effect - Clinical Codes	Burn(s) (1757); Injury (2348); Patient Problem/Medical Problem (2688); Partial thickness (Second Degree) Burn (2694)
Date of Event	12/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oasis is a 1.2 tesla vertical field (open) mri system.Hitachi service performed thermal testing on the unit and confirmed that the machine is working within specification and there is no evidence of a malfunction.The patient's abdomen was touching the magnet bore and there may not have been sufficient padding to prevent thermal injury from the radio frequency transmitter.
Event or Problem Description
A patient received a shoulder exam on the hitachi oasis mri system on (b)(6) 2017.The patient called site and left a voicemail 5 days after exam to report that he had redness on his belly which turned into blisters.The patient was scheduled to see his primary care doctor on (b)(6) 2017.Site has not seen the patient to confirm injury.

• Brand Name: OASIS
• Common Device Name: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): HITACHI LTD, HEALTHCARE BUSINESS UNIT; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• MDR Report Key: 7174826
• Report Number: 8030405-2017-00005
• Device Sequence Number: 10787241
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186(11)170711(250)G210097517
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K093044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Radiologic Technologist
• Device Model Number: OASIS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 181