FDA Adverse Event
Injury
Summary report: N
OPTITOP
MDR report key: 2218609
·
Received August 17, 2011
Report
- Report Number
- 2218609
- Event Type
- Injury
- Date Received
- August 17, 2011
- Date of Event
- July 16, 2011
- Report Date
- July 27, 2011
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Product Code
- IZO
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
THE PATIENT WAS LEANING ON THE TABLE THAT WAS LOCKED. THE UNIT POWER WAS REMOVED AND THE TABLE FREE-FLOATED WHEN POWER IS REMOVED WHICH CAUSED THE PATIENT TO FALL.WE ASKED THE MANUFACTURER IF THERE WAS A RETROFIT TO HAVE THE TABLE LOCK/BRAKE IF YOU LOSE POWER TO THE TABLE. THEY STATED "THERE WAS NOT A RETROFIT." WE HAVE A TOTAL OF 4 ROOMS LIKE THIS AT OUR FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTITOP | X-RAY SYSTEM | IZO | SIEMENS MEDICAL SOLUTIONS USA, INC. | 3345209X1953 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention | NO OTHER THERAPIES |