MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-12 for SWM4-PAT manufactured by Ge Medical Systems.
[20748256]
Nuclear medicine technician attempted to position the pt for a bone scan. The bone scan equipment malfunctioned, and the test could not start. The pt's test was cancelled. The pt was rescheduled to return on an alternate day for the test. Equipment technician was notified. There was no injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018997 |
| MDR Report Key | 1962616 |
| Date Received | 2011-01-12 |
| Date of Report | 2011-01-12 |
| Date of Event | 2011-01-11 |
| Date Added to Maude | 2011-01-20 |
| 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 | 0 |
| 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 |
| Generic Name | MG GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2011-01-12 |
| Model Number | SWM4-PAT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-12 |