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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION SYSTEM 1 EXPRESS
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STERIS CANADA CORPORATION SYSTEM 1 EXPRESS Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the system 1 express and found the battery for the control board required replacement.The technician replaced the battery, tested the unit, confirmed it to be operating according to specification, and returned it to service.A two-year complaint review indicates this to be an isolated event.No additional issues have been reported.
 
Event Description
The user facility reported they were unable to start a cycle on their system 1 express.Procedure delays were reported for the next day due to the unit being unavailable and the facility having no alternate processors available.
 
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Brand Name
SYSTEM 1 EXPRESS
Type of Device
SYSTEM 1 EXPRESS
Manufacturer (Section D)
STERIS CANADA CORPORATION
490 armand-paris
quebec, GIC 8 A3
CA  GIC 8A3
Manufacturer (Section G)
STERIS CANADA CORPORATION
490, armand-paris
quebec, GIC 8 A3
CA   GIC 8A3
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key9454072
MDR Text Key219568315
Report Number9680353-2019-00051
Device Sequence Number1
Product Code MED
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 11/11/2019
Initial Date FDA Received12/11/2019
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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