MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-21 for 3-T SYSTEM manufactured by Siemen's Corporation.
[632584]
Child was sedated and sleeping. The diffusion sequence was a 12-direction dti performed immediately after the localizers at the beginning of the protocol. Approximately half-way into the sequence, shortly after the diffusion gradients were applied, the child's arms and leg began to visibly twitch, followed by full flailing of the arms, dislodging the pulse oximeter. The dti scan was aborted and service rep did a savelog before the protocol was continued. After the child was re-sedated, the protocol was continued without the dti. A 3-direction, i. E. Dwi was applied at the end of the protocol. In this instance, there were no discernable involuntary movement observed nor was the child awakened by the scan. Date of use: one day in 2007. Diagnosis or reason for use: mri of the brain. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002808 |
| MDR Report Key | 871352 |
| Date Received | 2007-06-21 |
| Date of Report | 2007-06-21 |
| Date of Event | 2007-06-13 |
| Date Added to Maude | 2007-07-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3-T SYSTEM |
| Product Code | MRI |
| Date Received | 2007-06-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 855380 |
| Manufacturer | SIEMEN'S CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-21 |