FDA Adverse Event
Summary report: N
RELIANCE SYNERGY WASHER
MDR report key: 2781303
·
Received October 10, 2012
Report
- Report Number
- 9680353-2012-00077
- Date Received
- October 10, 2012
- Date of Event
- September 10, 2012
- Report Date
- October 10, 2012
- Manufacturer
- STERIS CANADA CORPORATION
- Product Code
- LDS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND A BREAK IN THE DRYER PISTON ASSEMBLY, ALLOWING WATER TO LEAK FROM THE WASHER THROUGH THE VENT HOSE. THE TECHNICIAN REPLACED THE BROKEN PARTS, RAN TEST CYCLES TO CONFIRM THE UNIT WAS OPERATING PROPERLY AND RETURNED IT TO SERVICE.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT A RELIANCE SYNERGY WASHER-DISINFECTOR LEAKED WATER ONTO THE FLOOR EXTENDING APPROXIMATELY 6 FEET FROM THE WASHER LOAD SIDE. NO INJURIES, PROCEDURE CANCELLATIONS OR WATER DAMAGE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RELIANCE SYNERGY WASHER | WASHER | LDS | STERIS CANADA CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |