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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION 220 CART WASHER

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STERIS CANADA CORPORATION 220 CART WASHER Back to Search Results
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/30/2014
Event Type  No Answer Provided  
Event Description
The user facility reported their cart washer has a bent piece of metal exposed which could create a safety hazard for employees.No report of injuries.
 
Manufacturer Narrative
A steris field service technician arrived onsite, inspected the unit, and identified the metal edge was on the double door's vertical center support.The technician determined this piece of sheet metal had bent over time due to impact damage from the loading carts.This type of damage is indicative of the carts being forcibly placed in the unit and contacting the door support creating an edge.The technician repaired and resecured the sheet metal to prevent a reoccurrence of an edge formation.The operator manual states, "wear appropriate personal protective equipment (ppe) whenever reaching into or entering wash chamber.".
 
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Brand Name
220 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 Key4467160
MDR Text Key5181332
Report Number9680353-2015-00011
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 01/29/2015
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/30/2014
Initial Date FDA Received01/29/2015
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
Patient Outcome(s) Other;
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