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

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018, the user facility contacted steris and reported a "component failure" on their eagle 3000 sterilizer.A steris service technician arrived on-site to inspect the unit and confirmed that cycles were not completing.To address the issue, the technician reset and calibrated the unit's pressure transducer.After resetting and calibrating the pressure transducer, the technician ran multiple test cycles, confirmed the sterilizer to be operating properly, and returned it to service.The cause of the reported issue is attributed to inadequate preventive maintenance by the user facility.Steris is the oem of the eagle 3000 sterilizer.The sterilizer subject of this medwatch report was manufactured and installed at the user facility in 2013 and is outside of the warranty period.Steris offers service agreements to all of our customers for routine preventive maintenance and servicing on all of our capital equipment.This customer elected to not enroll under a steris service agreement for this capital device.The facility's biomed department is responsible for performing all service and maintenance activities.If this device had been under a steris service agreement the pressure transducer would have been calibrated annually per the service and maintenance procedures.The eagle sterilizer operator manual states (1-2), "warning - personal injury hazard: regularly scheduled preventive maintenance is required for safe and reliable operation of this equipment.Contact your steris service representative to schedule preventive maintenance." while on-site, the technician counseled the user facility on the importance of conducting proper preventive maintenance activities, with focus on the annual calibration of the unit's pressure transducer.Steris has not been contacted regarding any additional issues with this unit since the service activity was performed in (b)(6) 2018.(b)(4).

Event Description

Reference medwatch report (b)(4).No injuries were associated with the reported event.

• Brand Name: EAGLE 3000 STERILIZER
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8071180
• MDR Text Key: 128918948
• Report Number: 3005899764-2018-00098
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2018

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: 10/15/2018
• Initial Date FDA Received: 11/14/2018
• 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 Number: 1