MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-06-11 for TOSHIBA MJAB-137A manufactured by Toshiba Medical Systems Corporation.
[4460751]
A patient allegedly suffered a skin burn/blister approximately the size of a dime and a nickel during an mri exam.
Patient Sequence No: 1, Text Type: D, B5
[12028615]
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.
Patient Sequence No: 1, Text Type: N, H10
[12082639]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020563-2014-00001 |
| MDR Report Key | 3867460 |
| Report Source | 05,06,07 |
| Date Received | 2014-06-11 |
| Date of Report | 2014-05-15 |
| Date of Event | 2014-05-14 |
| Date Mfgr Received | 2014-05-15 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2014-06-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. PAUL BIGGINS |
| Manufacturer Street | 2441 MICHELLE DRIVE |
| Manufacturer City | TUSTIN CA 92780 |
| Manufacturer Country | US |
| Manufacturer Postal | 92780 |
| Manufacturer Phone | 7147305000 |
| Manufacturer G1 | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 1385 SHIMOISHIGAMI |
| Manufacturer City | OTAWARA-SHI, TOCHIGI 324-8550 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 324-8550 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOSHIBA |
| Generic Name | MAGNETIC RESONANCE COIL |
| Product Code | MOS |
| Date Received | 2014-06-11 |
| Model Number | MJAB-137A |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 1385 SHIMOISHIGAMI OTAWARA-SHI, TOCHIGI 324-8550 JA 324-8550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-11 |