D
Patient 1
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR ORTHOVISION TABLE DID NOT RISE IN HEIGHT ALL THE WAY. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.
MAUDE MDR 3958101
- MDR report key
- 3958101
- Report number
- 1043572-2014-00062
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-06-21
- Date received
- 2014-07-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MS KATHRYN CADORETTE
- Address
- 5960 HEISLEY ROAD MENTOR OH 44060 US
- Phone
- 440-440-4403
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ORTHOVISION TABLE | SURGICAL TABLE | STERIS CORPORATION - MONTGOMERY | JEB | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-07-25 | 0 | 1. O |
Event Narratives#
N
Patient 1
A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY, INSPECTED THE TABLE AND CONFIRMED THE TABLE WAS OPERABLE. THE TECHNICIAN CHECKED THE HYDRAULIC FLUID LEVEL OF THE TABLE AND INSPECTED THE HYDRAULIC SYSTEM FOR LEAKS. THE TECHNICIAN CONFIRMED THE TABLE TO BE OPERATIONAL AND RETURNED IT TO SERVICE. STERIS OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE TABLE TO THE USER FACILITY AND IS AWAITING A RESPONSE.
N
Patient 1
STERIS' OFFER OF IN-SERVICE TRAINING WAS DECLINED BY THE USER FACILITY.