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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 220L CART WASHER
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STERIS CANADA CORPORATION RELIANCE 220L CART WASHER Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/03/2015
Event Type  No Answer Provided  
Event Description
The user facility reported their reliance 220 cart washer was leaking water.No report of injury.
 
Manufacturer Narrative
A steris field service technician arrived onsite, inspected the unit, and identified a leaking copper piping connection.The technician formed a new end on the copper piping piece, re-secured the piece, tested the unit, and confirmed it to be operating according to specification.The cart washer's piping connection loosened and deteriorated due to normal wear and usage.The unit has been installed and in use since 1998.
 
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Brand Name
RELIANCE 220L CART 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 Key4740167
MDR Text Key5703611
Report Number9680353-2015-00033
Device Sequence Number1
Product Code FLH
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 Health Professional
Type of Report Initial
Report Date 04/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2015
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 Received04/03/2015
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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