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

Model Number OASIS

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Issue (2379); Human Factors Issue (2948)

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

Event Date 12/22/2016

Event Type  Injury  

Manufacturer Narrative

The oasis is a 1.2 tesla vertical field (open) mri system.The transmitter and receive coil used on the patient were checked and found to be operating correctly.Clinical applications reviewed the patient images and found no image quality problems.Based on the information provided by the customer, we believe the root cause of the injury was that the patient's abdomen was contacting the mri transmitter cover and inadequate insulation was provided to prevent the rf energy from heating the patient's skin.Hitachi's applications helpline reminded the customer to always provide the proper amount of insulation between the body and covers as specified in the system operator's manual.

Event Description

The patient received a c-spine exam on the hitachi oasis mri system on (b)(6) 2016.The site reported they were using the c-spine coil, the patient was very large and his abdomen touched the top of the gantry.He reported discomfort right after the scan and the nurses and the radiologist examined him.Initially, there was some skin redness and a raised area, but no blistering.No treatment was given at that time.During subsequent followups, the patient stated that he had a 1/2 dollar size redness with a blister the day of mri.One week later he said that he had a "hole" in his skin with a black ring around it.The site's lead technologist spoke to the patient on 01/03/2017 and he said that he went to a walk-in clinic on monday (b)(6) to be seen.She spoke with the nurse at the clinic and she said they had gave him some antibiotics and told him to follow up with his primary care physician.The technologist then spoke with his primary care and they have tried to contact him to be seen and as of then had not reached him yet.The technologist also called him back and left a voicemail.No further contact has been made to the patient.

• 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: 6277071
• MDR Text Key: 65724555
• Report Number: 8030405-2016-00005
• 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: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• 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
• Date Manufacturer Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2014
• 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: 51 YR
• Patient Weight: 136