MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-31 for AURORA 1.5T BREAST MRI 01-04475-02 AURORA SYSTEM 128 manufactured by Aurora Imaging Technology, Inc..
[20008179]
A non mri safe oxygen tank was delivered by the vendor in error and was placed in the mri suite in error. The technologist moved the tank size "e" to give the pt oxygen she heard the tank move and grabbed it as it began to go toward the magnet. She was able to hold onto the tank on the side of the magnet as the pt was removed from the physician and staff. The magnet was quenched. The regulator hit the pt in the left upper arm as it went to the side of the magnet causing a laceration, the pt was transported to the hospital for stitches. The pt will fully recover. The mri suite became filled with a cloud of helium at the ceiling and began to move down towards the staff. The building was evacuated until the fire dept determined the air quality was safe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3653230 |
| MDR Report Key | 3653230 |
| Date Received | 2014-01-31 |
| Date of Report | 2014-01-26 |
| Date of Event | 2014-01-23 |
| Date Facility Aware | 2014-01-23 |
| Report Date | 2014-01-26 |
| Date Added to Maude | 2014-03-04 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | AURORA 1.5T BREAST MRI |
| Generic Name | MAGNETIC RESONANCE DIAGNOSTIC DEVICE |
| Product Code | LHN |
| Date Received | 2014-01-31 |
| Model Number | 01-04475-02 |
| Catalog Number | AURORA SYSTEM 128 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 7 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AURORA IMAGING TECHNOLOGY, INC. |
| Manufacturer Address | 16A ELECTRONICS AVENUE DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-01-31 |