MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-03 for CINEMAVISION MRI COMPATIBLE AUDIO/VIDEO GOGGLE SYSTEM RTC2K * manufactured by Resonance Tech, Inc..
[532335]
A pt was having a mri scan of the thoracic spine at our clinic. At the time of the event, the pt was using the cinemavision mri compatible audio/video goggle system to watch a television channel during the scan. During the scan, the pt informed me that he felt a hot spot i n the area of the right side of his groin. We entered the room and removed the pt from the mri unit. We discovered that the portion of the cable - part of the audio/video goggle system - that was overlying the pt's right groin was very hot. The pt stated that he was ok and we completed his test after removing the audio/video goggle system. After the test, while changing into his street clothes, the pt noticed a reddened area on his skin in the area where he felt the heat during the mri scan. The area was about 1 cm by 5 cm. We filed a very similar report about 2 weeks ago. The audio/video goggle system has been replaced since the previous report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1039951 |
| MDR Report Key | 752348 |
| Date Received | 2006-08-04 |
| Date of Report | 2006-08-03 |
| Date of Event | 2006-08-02 |
| Date Added to Maude | 2006-08-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CINEMAVISION MRI COMPATIBLE AUDIO/VIDEO GOGGLE SYSTEM |
| Generic Name | * |
| Product Code | HOY |
| Date Received | 2006-08-03 |
| Model Number | RTC2K |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 740140 |
| Manufacturer | RESONANCE TECH, INC. |
| Manufacturer Address | 18121 PARTHENIA ST STE A NORTHRIDGE CA 91325 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2006-08-04 |