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

Model Number	OASIS
Medical Device Problem Codes	Device Issue (2379); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Injury (2348); Patient Problem/Medical Problem (2688); Partial thickness (Second Degree) Burn (2694)
Date of Event	01/10/2018
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 skin was not touching the shoulder coil surface and the technologist used sufficient padding.The shoulder coil is a passive, receive-only device and is not capable of causing a thermal injury when working properly.Hitachi could not find a probable root cause of this event.
Event or Problem Description
A shoulder patient scanned on 1/10 complained of a burn 2 days later.The patient has redness around the shoulder where the coil was placed.The patient was in a gown and there was no direct contact with the coil to the patient.The patient did not complain of a burning sensation at the time of the exam or after the exam, only 2 days after the fact.The tech did not notice any heating on the coil at the time of the exam or on any other exam.On (b)(6), hitachi was notified that the patient is being treated by a physician with a burn ointment in the shoulder area, but it is unknown if the patient had blistering or just redness.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: 7259027
• Report Number: 8030405-2018-00001
• Device Sequence Number: 1222804
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186(11)160823(250)G210059416
• Combination Product (Y/N): N
• 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): 01/13/2018

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2018
• Initial Report FDA Received Date: 02/09/2018
• 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: 49 YR
• Patient Weight: 104