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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION EAGLE 3000 STERILIZER, STEAM

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STERIS CORPORATION EAGLE 3000 STERILIZER, STEAM Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/05/2019
Event Type  malfunction  
Event Description
Autoclave #2 not operational. Steam leak with test failure. Buildings and grounds notified. However, after seal replaced, the leak test still failed. Service technician notified. Seal replaced.
 
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Brand NameEAGLE 3000
Type of DeviceSTERILIZER, STEAM
Manufacturer (Section D)
STERIS CORPORATION
5960 heisley rd.
mentor OH 44060
MDR Report Key9314584
MDR Text Key166181209
Report Number9314584
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/31/2019,10/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/31/2019
Event Location Hospital
Date Report to Manufacturer11/13/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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