FDA Adverse Event
Summary report: N
RELIANCE SYNERGY WASHER
MDR report key: 2993261
·
Received March 7, 2013
Report
- Report Number
- 9680353-2013-00023
- Date Received
- March 7, 2013
- Date of Event
- February 7, 2013
- Report Date
- March 7, 2013
- Manufacturer
- STERIS CANADA CORPORATION
- Product Code
- MEC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY AND FOUND THE RECIRCULATION PUMP LEAKING. THE CAUSE OF THE LEAK WAS A DETERIORATED PUMP GASKET. THE UNIT WAS INSTALLED IN 2010 AND HAS NOT BEEN UNDER STERIS WARRANTY OR SERVICE CONTRACT SINCE (B)(6) 2011. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE PUMP GASKET, TESTED THE UNIT AND CONFIRMED THE UNIT WAS OPERATIONAL.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THE RELIANCE WASHER WAS LEAKING WATER ONTO THE FLOOR AND THROUGH MULTIPLE ROOMS. THERE WERE NO PROCEDURAL DELAYS/CANCELLATIONS OR INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97729 | RELIANCE SYNERGY WASHER | WASHER | MEC | STERIS CANADA CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |