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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER

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STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER Back to Search Results
Device Problems Device Inoperable (1663); Difficult to Open or Close (2921)
Patient Problem Injury (2348)
Event Date 10/16/2014
Event Type  No Answer Provided  
Event Description
The user facility reported their reliance synergy washer doors were not closing and the automated transport system attached to the washer was not functioning properly.An employee experienced a back strain while moving the manifold rack manually onto the automated transport system.The employee subject of the reported event sought medical treatment but has returned to normal work duties.No procedural delays or cancellations were reported.
 
Manufacturer Narrative
A steris field service technician arrived onsite, inspected the washer and transport system, and identified an active door obstruction alarm on the washer's loading side.The automated transport system was not pushing the rack manifolds completely into the washer's chamber.This caused the door obstruction alarm to activate thus preventing the washer doors from closing.The technician observed the puller/pusher mechanism was not making full contact with the rolling cylinders.The technician re-adjusted the automated transport system, tested the unit and system, and returned both to service according to specification.
 
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Brand Name
RELIANCE SYNERGY 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 Key4246195
MDR Text Key4987269
Report Number9680353-2014-00094
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,Followup
Report Date 11/12/2014
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 10/16/2014
Initial Date FDA Received11/12/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/20/2015
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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