MAUDE Adverse Event Report: HITACHI MEDICAL CORP., ECHELON; MAGNETIC RESONANCE IMAGING DEVICE

Model Number ECHELON

Device Problems Calibration Error (1078); Calibration Problem (2890)

Patient Problems Burning Sensation (2146); Injury (2348); Partial thickness (Second Degree) Burn (2694)

Event Date 12/19/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, a customer reported that a hospital inpatient reported skin burns after the completion of an mri exam on the hitachi echelon system.The patient reported the burn sensation after being transported to the floor.Patient had red area on right upper outer back which resolved within several hours.She had a left abdominal red area 11cmx21cm with a 1.5x1.5 blister.She also had red areas on the left and right buttock.Left lesion was 1cmx2cm; right was 6.5cmx3.0cm.There was also a linear red mark on a thigh that appeared to be caused by pressure.Later a nurse indicated that the blister had broke and was consistent with a second degree burn.

Manufacturer Narrative

The echelon is a 1.5 tesla closed bore mri system.From (b)(6) 2014, hitachi dispatched a field service engineer to investigate the incident.The spine receive coil and transmitter were heat tested and the tests were negative.The ctl temp was 75 deg f, the transmitter 80 deg f.The transmitter tuning was checked and found to be out of specification.A bad tuning capacitor was found and replaced.The transmitter was retuned and is now properly aligned.Even though the transmitter was mistuned, the transmitter gain was in the normal range, so rf power output was within specification.Service also found that one of the gantry bore fans was partially blocked by lint.The last preventive maintenance visit where the fans were checked was in (b)(6) 2014.(pms are quarterly.) clinical applications reviewed the patient images and found good image quality and no evidence of a malfunction.Sar values ranged from 0.97 to 2.21 w/lg.Total scan time was approximately 27-28 minutes each for a t and l spine exam.Room temp and humidity were within specification.Evidence suggests that, due to the patient's size, the body was close to the transmitter coil surface (bore) and the partially blocked fan reduced airflow.There was no evidence of skin to skin contact (causing rf current loop) but we cannot rule it out.

• Brand Name: ECHELON
• Type of Device: MAGNETIC RESONANCE IMAGING DEVICE
• Manufacturer (Section D): HITACHI MEDICAL CORP.,; 2-1, shintoyofuta; kashiwa-shi, chiba 277 ; JA 277
• Manufacturer Contact: doug thistlethwaite ; 1959 summit commerce park; twinsburg, OH 44087 ; 3304251313
• MDR Report Key: 4490993
• MDR Text Key: 5344228
• Report Number: 8030405-2015-00001
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ECHELON
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2007
• 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: 66 YR
• Patient Weight: 135