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

Model Number OASIS

Device Problems Device Issue (2379); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Injury (2348); Patient Problem/Medical Problem (2688); Partial thickness (Second Degree) Burn (2694)

Event Date 05/16/2018

Event Type  Injury  

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 body coil surfaces and the technologist used sufficient padding.The two coils used are passive, receive-only device and is not capable of causing a thermal injury when working properly.Image evaluation indicated normal image quality.The site did not see the patient after the report nor received a physician's report to confirm the extent of the injury.Note that the report was made 10 days after the exam.Hitachi could not find a probable root cause of this event.

Event Description

A patient's family called on saturday (b)(6) 2018 to report that the patient was currently in the emergency room with burns and blisters due to an mri scan done on the hitachi oasis mri at (b)(6) radiology.The patient was scanned on (b)(6) 2018 for both at thoracic spine and a lumbar spine using receive-only body coils.At time of the mri the patient did not complain of any discomfort, nor note any blistering or burning.No other patients have noted any heating on any coil on the system.(b)(6) reported the incident to hitachi healthcare americas on 05/29/2018.

• Brand Name: OASIS
• Type of Device: 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
• Manufacturer (Section G): HITACHI LTD. HEALTHCARE BUSINESS UNIT; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer Contact: douglas thistlethwaite ; 1959 summit commerce park; twinsburg, OH 44087 ; 3304251313
• MDR Report Key: 7638992
• MDR Text Key: 112372928
• Report Number: 8030405-2018-00003
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 05/29/2018

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
• Device Operator: Radiologic Technologist
• Device Model Number: OASIS
• 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?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 118