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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 130L CART WASHER; RELIANCE CART WASHER
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STERIS CANADA CORPORATION RELIANCE 130L CART WASHER; RELIANCE CART WASHER Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/04/2018
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite following the reported event.While inspecting the unit, the technician found that a seal on the recirculation pump had broken, resulting in the reported water leak.To resolve the issue, the technician replaced the recirculation pump, seal and motor, ran a test cycle, and found the unit to be operational.The washer was returned to service.The unit was manufactured in 2005 and is under steris service agreement.
 
Event Description
The user facility reported water leaking from their reliance 130l cart washer.No report of injury.
 
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Brand Name
RELIANCE 130L CART WASHER
Type of Device
RELIANCE CART 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 Key7656727
MDR Text Key113202247
Report Number9680353-2018-00057
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 07/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
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
Date Manufacturer Received06/04/2018
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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