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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER/DISINFECTOR TRANSFER CARTS
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STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER/DISINFECTOR TRANSFER CARTS Back to Search Results
Device Problem Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2015
Event Type  No Answer Provided  
Manufacturer Narrative
A dta technician arrived on site, inspected the transfer carts, and identified the wheels required replacement.The technician replaced the wheels, tested the locking mechanisms, and confirmed the transfer carts were operating according to specification.Section 3.2 of the transfer cart's operator manual states, "inspect wheels to ensure they roll smoothly.Align if they are misaligned, replace if worn or if brakes are broken." no additional issues have been reported.
 
Event Description
The user facility reported the wheels on their transfer carts utilized with their reliance synergy washer/disinfector would not remain in a locked position.No report of injury.
 
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Brand Name
RELIANCE SYNERGY WASHER/DISINFECTOR TRANSFER CARTS
Type of Device
RELIANCE SYNERGY 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 Key5052942
MDR Text Key25537658
Report Number9680353-2015-00055
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Report Date 09/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/05/2015
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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