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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. EAGLE 3000 STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. EAGLE 3000 STERILIZER Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the eagle 3000 sterilizer and found that the unit could not pull a sufficient vacuum. Upon further inspection, the technician found several parts of the sterilizer were damaged including the s7, s3, and s4 valves. The sterilizer was installed in march 2005 making the unit approximately 14 years old at the time of the reported event. The technician made the necessary repairs, ran a test cycle, and found the sterilizer to be operating according to specification. Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803. It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies. No additional issues have been reported. (b)(4).
 
Event Description
The user facility reported via medwatch # (b)(4) their eagle 3000 sterilizer was not operating properly. No report of injury.
 
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Brand NameEAGLE 3000 STERILIZER
Type of DeviceSTERILIZER
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX 67190
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX 67190
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key9495764
MDR Text Key199552660
Report Number3005899764-2019-00095
Device Sequence Number1
Product Code FLE
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 Health Care Professional
Type of Report Initial
Report Date 12/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2019
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?
Event Location No Information
Date Manufacturer Received11/19/2019
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

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