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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 Problem Burst Container or Vessel (1074)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/17/2015
Event Type  No Answer Provided  
Manufacturer Narrative
The user facility reported a scrub technician was standing next to the washer during the time of the reported event; the employee's eardrum ruptured due to the noise of the burst pipe.Another employee present stated they did not feel well and sought medical treatment.The steris service technician present reported he was fine.The steris service technician inspected the washer and found the hose connecting the facility shutoff valve to the washer's steam pipe had burst.The steam pipe subject of the reported event was not properly installed by the user facility prior to the steris service technician's start up of the washer.The user facility re-piped the washer and steris was able to successfully start-up the washer, run a test cycle and place the washer into service.No additional issues have been reported.The washer was manufactured in 2009 and is serviced and maintained by the user facility.
 
Event Description
The user facility had completed the re-install of their reliance synergy washer and contacted steris to start up the unit.The steris service technician was running the first test cycle and during this cycle the steam pipe burst.
 
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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 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 Key5156127
MDR Text Key28848585
Report Number9680353-2015-00069
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
Report Date 10/16/2015
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/16/2015
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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