MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 20" EAGLE STERILIZER

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event.While inspecting the unit, the technician found that one of the contactors within the unit's steam generator was melted.As the contactor sustained damage, it did not activate the heater element to turn off subsequently causing the reported event.To resolve the issue, the technician replaced the contactor and heater, ran a test cycle and found the unit to be operating according to specifications.The unit was returned to service.The unit was manufactured in 2001 and is under steris service agreement.No additional issues have been reported.

Event Description

The user facility reported an electrical issue with their 20" eagle sterilizer.No report of injury, procedure delay, or cancellations.

• Brand Name: 20" EAGLE 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: 7724336
• MDR Text Key: 115398891
• Report Number: 3005899764-2018-00072
• Device Sequence Number: 0
• 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: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2018
• 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