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

Model Number MJAB-137A/S1

Device Problem Insufficient Information (3190)

Patient Problem Erythema (1840)

Event Date 04/01/2015

Event Type  Injury  

Event Description

A patient allegedly sustained two quarter-sized areas of redness and tenderness bilaterally at the anterior, superior spine during an mri scan.

Manufacturer Narrative

A patient was scanned for a pelvis and lower extremity, thigh to knee in a toshiba mri system using a qd torso speeder coil.Allegedly the patient complained of a warming sensation in her pelvic region when contrast was injected.The patient allegedly sustained two quarter-sized areas of redness and tenderness bilaterally at the area of the anterior, superior spine.The patient was examined by a physician and an rn and no blistering was seen.Follow-up calls were placed to the patient at 6 and 24 hours later.At 6 hours no worsening and at 24 hours the patient indicated that the tenderness was gone and redness was slowly dissipating.The coil was inspected one day following the scan and no physical damage was noted.Qa scans for the coil were performed and it did not meet one of the specifications but is not related to the event.The coil is being replaced for the customer and the original coil is being returned to the manufacturer.

Manufacturer Narrative

The coil was returned to the manufacturer for investigation.It was determined that the cause of the problem was damage to the anterior connector of the coil.It is believed that the damage to the anterior connector caused the feet scan of the coil to not meet the snr specification.This in turn caused the surface temperature of the coil to rise, causing the burn to the patient.

• 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: 4743749
• MDR Text Key: 5887052
• Report Number: 2020563-2015-00002
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Radiologic Technologist
• Device Model Number: MJAB-137A/S1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 55