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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE VISION SINGLE CHAMBER WASHER/DISINFECTOR
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STERIS CANADA CORPORATION RELIANCE VISION SINGLE CHAMBER WASHER/DISINFECTOR Back to Search Results
Device Problem Smoking (1585)
Patient Problem Irritation (1941)
Event Date 10/22/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the reliance vision washer and found that the drying elements including the heater and contactor were damaged.The unit was removed from service following the reported event and the customer is awaiting a replacement washer.The damaged washer and its components are being returned to steris quality for further evaluation.Investigation of this event is currently in process.A follow-up mdr will be submitted when additional information becomes available.
 
Event Description
The user facility reported smoke was emitting from their reliance vision washer causing procedure delays.User facility personnel immediately shut off power to the unit.Two employees reported inhalation/irritation effects due to the reported smoke.The employees sought medical treatment however, the user facility would not disclose whether medical treatment was administered.
 
Manufacturer Narrative
Based on the investigation performed by steris, the c4 contactor was stuck in the closed position which allowed the drying elements to overheat and the reported event to occur.The user facility was provided with a replacement washer.No additional issues have been reported.
 
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Brand Name
RELIANCE VISION SINGLE CHAMBER WASHER/DISINFECTOR
Type of Device
WASHER
Manufacturer (Section D)
STERIS CANADA CORPORATION
490 armand-paris
quebec, GIC 8 A3
CA  GIC 8A3
MDR Report Key9359030
MDR Text Key174715812
Report Number9680353-2019-00046
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
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 Received10/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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