MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-07-01 for TOSHIBA MJAB-137A manufactured by Toshiba Medical Systems Corporation.
[48664699]
During a procedure a patient moved from his original position that he was placed in by the technician - arms across chest. The patient moved his arms to the side of his body which caused them to come into contact with the coil cable for remainder of the study. The patient complained of a slight burning sensation on his left inner arm after completion of the study. Patient was sent to the er. The qd torso speeder coil used was tested and coil performed correctly with no issues. It was found when checking the patient images that the patient's arm was in the field of view (fov). This indicated the improper positioning of the patient for the type of study that was being performed.
Patient Sequence No: 1, Text Type: N, H10
[48664700]
Patient complained of burning sensation on arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020563-2016-00003 |
| MDR Report Key | 5765499 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-07-01 |
| Date of Report | 2016-06-07 |
| Date of Event | 2016-06-03 |
| Date Mfgr Received | 2016-06-07 |
| Date Added to Maude | 2016-07-01 |
| 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 EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 2016-07-01 |
| Model Number | MJAB-137A |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-07-01 |