MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-28 for E-CAM E CAM/ESOFT P * manufactured by Siemens Medical Solutions Usa, Inc..
[1156194]
One of the technicians pressed the print button about 45 minutes into a study and the workflow closed. When restarted the exam could not be found. The acquisition and machine log files were retrieved and sent to siemens for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1375926 |
| MDR Report Key | 1375926 |
| Date Received | 2009-04-28 |
| Date of Report | 2009-04-23 |
| Date of Event | 2009-04-20 |
| Report Date | 2009-04-23 |
| Date Reported to FDA | 2009-04-28 |
| Date Added to Maude | 2009-05-07 |
| 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 | 0 |
| 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 | E-CAM |
| Generic Name | NUCLEAR CAMERA |
| Product Code | IYX |
| Date Received | 2009-04-28 |
| Model Number | E CAM/ESOFT P |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 10 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 51 VALLEY STREAM PARKWAY MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-28 |