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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE VISION MULTI-CHAMBER WASHER
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STERIS CANADA CORPORATION RELIANCE VISION MULTI-CHAMBER WASHER Back to Search Results
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2016
Event Type  No Answer Provided  
Manufacturer Narrative
A steris service technician inspected the washer and found the washer's load door had come out of the track and the right side of the sensor bar had disconnected from the washer.The technician put the washer door back on the track and re-installed the sensor bar.The technician ran a test cycle and confirmed the washer to be operating properly.
 
Event Description
The user facility reported that their washer door was off the track and that one side of the sensor bar had disconnected from the washer.No report of injury.
 
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Brand Name
RELIANCE VISION MULTI-CHAMBER 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 Key5864882
MDR Text Key52492073
Report Number9680353-2016-00074
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 08/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2016
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 Received07/11/2016
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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