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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION AMSCO 5052 WASHER
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STERIS CANADA CORPORATION AMSCO 5052 WASHER Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/28/2017
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the washer and found that the cause of the leak was due to a condensate water valve and water level switch assembly not operating properly.The technician repaired the washer, ran a test cycle and confirmed the washer to be operating properly.The washer was returned to service and no additional issues have been reported.
 
Event Description
The user facility reported that their washer chamber filled with water and was not draining properly.An employee opened the door subsequently causing water to leak out onto the floor.
 
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Brand Name
AMSCO 5052 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
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key6898239
MDR Text Key87729164
Report Number9680353-2017-00067
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 09/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/28/2017
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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