N
Patient 1
THE TABLE DRIFT WAS RESOLVED BY REPLACING THE CHECK VALVE BLOCK IN THE MANIFOLD. THE TABLE WAS TESTED TO VERIFY PROPER FUNCTION.
MAUDE MDR 7403791
- MDR report key
- 7403791
- Report number
- 3010326005-2018-00030
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-03-13
- Date received
- 2018-04-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR TODD SPERLING
- Address
- 5101 SHADY OAK ROAD MINNETONKA MN 55343 US
- Phone
- 763-763-7632
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | IMRIS ORT300 OPERATING ROOM TABLE | OPERATING ROOM TABLE | IMRIS - DEERFIELD IMAGING, INC. | KXJ | ORT300 | 114093-000 | N/A | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-04-06 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER STATED THAT THE ORT300 TABLE IS DRIFTING IN THE TRENDELENBURG OVERNIGHT WHEN NOT IN USE WHILE UNLOADED. OBSERVED DURING DAILY QA/ INSPECTION.