D
Patient 1
THE COMPLAINANTT REPORTED THAT DURING PATIENT TESTING, THE ROCKER SWITCH WAS PUSHED TO LOWER THE TABLE AND THE TABLE KEPT GOING DOWN WHEN THE SWITCH WAS RELEASED. THERE WAS NO REPORTED INJURY TO THE PATIENT.
MAUDE MDR 786059
- MDR report key
- 786059
- Report number
- 9615030-2004-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2004-12-01
- Date received
- 2004-12-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Address
- 5160 HACIENDA DR DUBLIN CO 94568 US
- Phone
- 925-925-9255
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FF450 POWER TABLE | INSTRUMENT TABLE | CARL ZEISS MEDITEC AG | INQ | IT -3F | NA | NA | N | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2004-12-23 | 0 |
Event Narratives#
N
Patient 1
THE TABLE IN QUESTION IS BEING RETURNED FOR EVALUATION. AS OF THE SUBMISSION OF THIS REPORT, THE TABLE HAS NOT BEEN RECEIVED FOR EVALUATION. A SEPARATE FOLLOW-UP WILL BE SUBMITTED ONCE THE TABLE IS EVALUATED.