MAUDE Adverse Event Report: TOSHIBA MEDICAL SYSTEMS CORPORATION TOSHIBA; MAGNETIC RESONANCE COIL

Model Number MJAB-137A

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Burn, Thermal (2530)

Event Date 05/14/2014

Event Type  Injury  

Event Description

A patient allegedly suffered a skin burn/blister approximately the size of a dime and a nickel during an mri exam.

Manufacturer Narrative

The manufacturer has investigated this issue and has determined the cause was the placement of the coil cable.It was found that the coil cable, patient's body and arm became an rf loop with capacitance.Rf current flowed thru the capacitive loop between the coil cable and the patient's arm.Foam pads should be used instead of the towel that was used between the coil and the patient's arm.Data for the coil and the rf transmission were reviewed by the manufacturer after the problem occurred and was found to be normal.The manual for the coil contains the following caution statements: route the cable that connects the anterior and posterior units of the coil properly so that it does not come into contact with the patient.If contact is unavoidable, foam pads with a compressed thickness of 1 cm should be placed between the cable and the patient.Direct contact can result in burns.If the patient's arm or shoulder or the anterior unt of the qd torso speeder comes into direct contact with the qd whole body coil (inner wall of the magnet assembly), foam pads with a compressed thickness of 1 cm should be placed between the qd whole-body coil and the patient or the anterior unit.Direct contact can result in burns.

Manufacturer Narrative

During an mri exam, a patient allegedly complained that the coil cable was getting hot.Prior to the start of the exam, the technologist wrapped the coil cable in a towel so that it would not be in direct contact with the patient.The technologist allegedly stated that she put a second towel between the patient and the coil cable and the heat lessened.Once the exam was completed, the technologist looked at the patient's arm and found that he had a red mark on his forearm where the cable had been resting.When the patient arrived home, he said that a blister had formed.The next day the patient said that the blister had popped and that he would notify them of any change.The coil is being returned to the manufacturer for evaluation.No results since evaluation has not begun.

• Brand Name: TOSHIBA
• Type of Device: MAGNETIC RESONANCE COIL
• Manufacturer (Section D): TOSHIBA MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324- 8550; JA 324-8550
• Manufacturer (Section G): TOSHIBA MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324- 8550; JA 324-8550
• Manufacturer Contact: paul biggins ; 2441 michelle drive; tustin, CA 92780 ; 7147305000
• MDR Report Key: 3867460
• MDR Text Key: 4460751
• Report Number: 2020563-2014-00001
• Device Sequence Number: 1
• Product Code: MOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Model Number: MJAB-137A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2014
• Date Device Manufactured: 05/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 104