MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STERILIZER

Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found one of the contactors stuck in the heaters of the generator.As the contactor was stuck in the closed position, this allowed continuous power to be provided to the unit causing excess steam to build up.As designed, the safety valve opened, and excess steam emitted from the unit; no smoke or flames were observed.The device history record for the unit was reviewed and confirmed the unit was manufactured according to specifications.The technician replaced the contactor and necessary components.After the unit was tested and confirmed operating according to specifications it was returned to service.No additional issues have been reported.
Event or Problem Description
The user facility reported a burning smell and steam leak from their amsco 400 sterilizer.There was a procedure delay reported as a result of the event.No report of injury.

• Brand Name: AMSCO 400 STERILIZER
• Common Device Name: STERILIZER
• 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
• MDR Report Key: 19144894
• Report Number: 3005899764-2024-00018
• Device Sequence Number: 18003188
• Product Code: FLE
• UDI-Device Identifier: 00724995209537
• UDI-Public: 00724995209537
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown