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)

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

Event Date 11/28/2018

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 touching the top trasmitter and the technologist did not use sufficient padding.Hitachi's operator manual states that proper padding is required.Image evaluation indicated good image quality.The sar level is within normal specification.

Event Description

Patient was burned while being scanned on (b)(6) 2018 on an oasis mri.The mri facility was scanning a large patient with the dedicated c-spine coil.Patient was touching the top transmitter with their belly, mri tech states a thin pad was used, but patient says the pad was not covering the entire area including the area that was burnt.Patient initially had a red area, couple hours later a blister appeared and the next day it was larger.Patient was treated at a wound center on (b)(6) 2018 and returned to the mri facility on (b)(6) 2018 for their doctor to take a look at it.Patient was treated with silvadene cream and antibiotic.

• 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: aaron pierce ; 1959 summit commerce park; twinsburg, OH 44087 ; 3304251313
• MDR Report Key: 8178509
• MDR Text Key: 130785103
• Report Number: 8030405-2018-00008
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/05/2018

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: Health Professional
• Device Model Number: OASIS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2010
• 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: 45 YR
• Patient Weight: 217