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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 Burst Container or Vessel (1074); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/15/2014
Event Type  No Answer Provided  
Event Description
The user facility reported the facility's utility pipe had burst releasing steam and water onto the floor.The leak was not attributed to the steris washer.No injuries were reported.
 
Manufacturer Narrative
A steris field service technician arrived onsite, inspected the washer, and confirmed the unit to be operating according to specification.The technician inspected the facility pipe connected to the washer and the facility steam trap.The facility pipe had ruptured and the steam trap had failed which allowed steam to leak and condensation to form water on the floor.
 
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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 Key4417864
MDR Text Key5419946
Report Number9680353-2015-00003
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 01/14/2015
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 12/15/2014
Initial Date FDA Received01/14/2015
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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