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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION 130 CART WASHER
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STERIS CANADA CORPORATION 130 CART WASHER Back to Search Results
Device Problems Fire (1245); Smoking (1585); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/05/2015
Event Type  No Answer Provided  
Event Description
The user facility reported an electrical fire which emitted smoke thus activating the fire alarm.No report of injuries or procedural delays or cancellations.The department was evacuated.
 
Manufacturer Narrative
A steris field service technician arrived onsite, inspected the unit, and identified the drying fan had overheated.The technician replaced the drying fan and affected fuses, tested the unit, confirmed it to be operating according to specification, and returned the unit to service.
 
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Brand Name
130 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 Key4488817
MDR Text Key5500668
Report Number9680353-2015-00017
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 02/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2015
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 Received01/05/2015
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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