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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 444 WASHER
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STERIS CANADA CORPORATION RELIANCE 444 WASHER Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Information (3190)
Event Date 08/02/2017
Event Type  malfunction  
Manufacturer Narrative
No report of injury, procedure delay or cancellation.The water leak was not contained to the footprint of the unit.User facility personnel immediately cleaned the water up off the floor around the unit.A steris service technician arrived onsite to inspect the reliance 444 washer and found that the cold-water condenser hose had detached from the condenser tank due to a broken clamp.The technician reconnected the cold-water condenser hose with a new clamp, ran a test cycle, and confirmed the unit to be operating according to specification.The unit was manufactured in 2002 and is currently serviced and maintained by steris.
 
Event Description
The user facility reported that their reliance 444 washer was leaking water onto the floor.
 
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Brand Name
RELIANCE 444 WASHER
Type of Device
WASHER
Manufacturer (Section D)
STERIS CANADA CORPORATION
490 armand-paris
quebec, quebec GIC 8 A3
CA  GIC 8A3
Manufacturer (Section G)
STERIS CANADA CORPORATION
490, armand-paris
quebec, quebec GIC 8 A3
CA   GIC 8A3
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key6830068
MDR Text Key84125122
Report Number9680353-2017-00061
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
Type of Report Initial
Report Date 08/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/02/2017
Initial Date FDA Received08/30/2017
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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