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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION 120 CART WASHER
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STERIS CANADA CORPORATION 120 CART WASHER Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/03/2014
Event Type  No Answer Provided  
Event Description
The user facility reported that their washer was leaking hot water and steam.No injuries or procedural delays/cancellations were reported.
 
Manufacturer Narrative
The hot water leak was contained within the unit's chamber and did not exit the unit.The steam leak was external, however, water did not accumulate on the floor.Two steris field service technicians inspected the washer and identified that the washer required several repairs including replacement of the heat exchanger and the steam valve.
 
Manufacturer Narrative
The heat exchanger has been replaced.The unit was tested and returned to service.No additional issues were reported.
 
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Brand Name
120 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 Key4140611
MDR Text Key17994743
Report Number9680353-2014-00082
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2014
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 Received09/03/2014
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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