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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE GENFORE WASHER
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STERIS CANADA CORPORATION RELIANCE GENFORE WASHER Back to Search Results
Device Problems Fluid/Blood Leak (1250); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2014
Event Type  No Answer Provided  
Event Description
The user facility reported their washer was emitting a loud noise and spraying water onto the floor.No injuries or procedural delays or cancellations were reported.
 
Manufacturer Narrative
A steris field service technician arrived onsite, inspected the unit, and identified a broken drying piston valve.The technician replaced the drying piston valve and o-rings, tested the unit, and returned the washer to service according to specification.
 
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Brand Name
RELIANCE GENFORE WASHER
Type of Device
WASHER
Manufacturer (Section D)
STERIS CANADA CORPORATION
490 armand-paris
quebec, quebec GIC 8A3
CA  GIC 8A3
Manufacturer (Section G)
STERIS CANADA CORPORATION
490, armand-paris
quebec, quebec GIC 8A3
CA   GIC 8A3
Manufacturer Contact
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key4266717
MDR Text Key18932029
Report Number9680353-2014-00095
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/23/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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