MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-20 for SDU-450XL * manufactured by Shimadzu Medical Systems.
[3021159]
Physician was reviewing numerous scans from the previous day and complained that the quality of the images were of not as clear as he would like. There were no changes to the patients' plan of care. Testing continued at normal intervals. The tests were done by the same physician and the physician is very experienced. A commonality between all involved patients is obesity--patients were pregnant. Outside of this report, we have not had a trend with this device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2803909 |
| MDR Report Key | 2803909 |
| Date Received | 2012-09-20 |
| Date of Report | 2012-09-20 |
| Date of Event | 2012-04-26 |
| Report Date | 2012-09-20 |
| Date Reported to FDA | 2012-09-20 |
| Date Added to Maude | 2012-10-25 |
| 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 | RISK MANAGER |
| 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 | SDU-450XL |
| Generic Name | SYSTEM, ULTRASOUND |
| Product Code | HEM |
| Date Received | 2012-09-20 |
| Model Number | SDU-450XL |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 12 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHIMADZU MEDICAL SYSTEMS |
| Manufacturer Address | 20101 SOUTH VERMONT AVE. TORRANCE CA 90502132 US 90502 1328 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-20 |