MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-14 for SONIALVISION VERSA 100R/100 DAR 8000I * manufactured by Shimadzu Medical Systems.
[3240429]
Patient was undergoing a dysphagia study, since this patient was ambulatory, the patient was allowed to sit on the foot board in an upright position for the test. The radiology tech tested (sat on) the foot board prior to the patient sitting on it and it tested fine. As the patient sat on the foot board for the scout image, she immediately fell to the floor. The patient did strike her side, but x-rays of the ribs were negative for fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2876917 |
| MDR Report Key | 2876917 |
| Date Received | 2012-11-14 |
| Date of Report | 2012-11-14 |
| Date of Event | 2012-11-09 |
| Report Date | 2012-11-14 |
| Date Reported to FDA | 2012-11-14 |
| Date Added to Maude | 2012-12-18 |
| 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 | SONIALVISION VERSA 100R/100 DAR 8000I |
| Generic Name | TABLE, RADIOGRAPHIC, NON-TILTING, POWERED |
| Product Code | IZZ |
| Date Received | 2012-11-14 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | OP11502005N |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHIMADZU MEDICAL SYSTEMS |
| Manufacturer Address | 20101 SOUTH VERMONT AVE. TORRANCE CA 90502 US 90502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-14 |