FDA Adverse Event
Summary report: N
SONIALVISION VERSA 100R/100 DAR 8000I
MDR report key: 2876917
·
Received November 14, 2012
Report
- Report Number
- 2876917
- Date Received
- November 14, 2012
- Date of Event
- November 9, 2012
- Report Date
- November 14, 2012
- Manufacturer
- SHIMADZU MEDICAL SYSTEMS
- Product Code
- IZZ
- Report Source
- User Facility report
- Reporter Location
- TN, US
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SONIALVISION VERSA 100R/100 DAR 8000I | TABLE, RADIOGRAPHIC, NON-TILTING, POWERED | IZZ | SHIMADZU MEDICAL SYSTEMS | * | OP11502005N |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | NO OTHER THERAPIES |