FDA Adverse Event
Summary report: N
RELIANCE EPS
MDR report key: 2508272
·
Received March 28, 2012
Report
- Report Number
- 9680353-2012-00022
- Date Received
- March 28, 2012
- Date of Event
- February 28, 2012
- Report Date
- March 28, 2012
- Manufacturer
- STERIS CANADA CORPORATION
- Product Code
- NZA
- PMA / PMN Number
- K102244
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A STERIS TECHNICIAN INSPECTED THE UNIT AND FOUND THE HOSE CLAMP ON THE UNIT'S HOT WATER SUPPLY LINE HAD LOOSENED, CAUSING THE HOSE TO COME OFF THE FITTING AND WATER TO LEAK. THE TECHNICIAN REPLACED THE HOSE AND CLAMP, TIGHTENED ALL CONNECTIONS 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 DEPARTMENT. NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RELIANCE EPS | WASHER/DISINFECTOR | NZA | STERIS CANADA CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |