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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 444 WASHER/DISINFECTOR
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STERIS CANADA CORPORATION RELIANCE 444 WASHER/DISINFECTOR Back to Search Results
Device Problems Leak/Splash (1354); Failure to Align (2522)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/23/2016
Event Type  No Answer Provided  
Manufacturer Narrative
A steris service technician inspected the washer and found that the drain pipe was misaligned.The technician re-centered the drain pipe, ran a test cycle and confirmed the washer to be operating properly.No additional issues have been reported.The drain pipe on the washer is accessible without opening the access panel.It is likely that user facility staff maintenance and/or cleaning activities caused the repositioning of the drain pipe from the proper position.
 
Event Description
The user facility reported that the drain pipe for their reliance 444 washer was not centered over the drain subsequently causing water to splash onto the floor.No report of injury.
 
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Brand Name
RELIANCE 444 WASHER/DISINFECTOR
Type of Device
WASHER/DISINFECTOR
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
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key5492592
MDR Text Key40085602
Report Number9680353-2016-00020
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 03/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/23/2016
Initial Date FDA Received03/10/2016
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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