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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE VISION SINGLE CHAMBER WASHER; WASHER/DISINFECTOR
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STERIS CANADA ULC RELIANCE VISION SINGLE CHAMBER WASHER; WASHER/DISINFECTOR Back to Search Results
Device Problems Fluid/Blood Leak (1250); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2021
Event Type  malfunction  
Event Description
The user facility reported water was leaking from their reliance vision single chamber washer/disinfector.No report of injury.
 
Manufacturer Narrative
The investigation subject of the event is in process; a follow-up mdr will be submitted when additional information becomes available.
 
Manufacturer Narrative
Based on the technician's inspection the welds that hold the press gasket in place were broken subsequently allowing water to leak onto the floor.The technician made the necessary repairs, tested the unit, confirmed it was operating according to specifications, and returned the unit to service.No additional issues have been reported.
 
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Brand Name
RELIANCE VISION SINGLE CHAMBER WASHER
Type of Device
WASHER/DISINFECTOR
Manufacturer (Section D)
STERIS CANADA ULC
490 boulevard armand-paris
quebec, G1C 8 A3
CA  G1C 8A3
Manufacturer (Section G)
STERIS CANADA ULC
490 boulevard armand-paris
quebec, G1C 8 A3
CA   G1C 8A3
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key13027596
MDR Text Key283956996
Report Number9680353-2021-00048
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeCA
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 12/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
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
Date Manufacturer Received11/18/2021
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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