FDA Adverse Event
Summary report: N
RELIANCE EPS
MDR report key: 2470087
·
Received February 27, 2012
Report
- Report Number
- 9680353-2012-00016
- Date Received
- February 27, 2012
- Date of Event
- February 1, 2012
- Report Date
- February 27, 2012
- Manufacturer
- STERIS CANADA CORPORATION
- Product Code
- NZA
- PMA / PMN Number
- K040049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A STERIS TECHNICIAN INSPECTED THE UNIT AND FOUND THE HOSE CLAMP ON THE UNIT'S WATER LINE HAD LOOSENED CAUSING THE HOSE TO COME OFF THE FITTING AND WATER TO LEAK. THE TECHNICIAN REPLACED THE HOSE AND CLAMP AND PLACED THE UNIT BACK INTO SERVICE. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THIS EQUIPMENT.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT THE HOSE ON THE WATER LINE OF THE RELIANCE ENDOSCOPE PROCESSING UNIT DISCONNECTED AND FLOODED THE LABORATORY. NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RELIANCE EPS | HIGH LEVEL DISINFECTION WASHER | NZA | STERIS CANADA CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |