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

Model Number	AMSCO 400 STEAM STERILIZER
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the viewport was damaged allowing water and steam to leak from the unit.The technician replaced the viewport, tested the unit, confirmed it to be operating according to specification, and returned the sterilizer to service.While onsite, the technician collected water samples to test the facility's incoming water.A follow-up mdr will be submitted once additional information becomes available.No additional issues have been reported.
Event or Problem Description
The user facility reported that their amsco 400 sterilizer emitted a "loud bang" noise following a water and steam leak.Due to the loud noise, the user facility sent the employee in the room at the time of the reported event to a hearing consultation.The user facility did not disclose any additional information.
Additional Manufacturer Narrative
A steris service technician collected water samples to be tested.The results identified that three of the critical chemical attributes of water quality were above the maximum requirements and one of the critical attributes was below the requirements for the electric steam generator as stated in the amsco 400 sterilizer operator manual (table 5-1.Required feed water quality for carbon steel generators).The user facility is responsible for ensuring that their incoming water supply remains within the electric steam generator's operating requirements.The amsco 400 sterilizer operator manual states (3-1), "water quality - supplied must be within specifications.Improper water quality adversely affects equipment operation." the technician notified user facility personnel of the water quality test results and that their water quality is not meeting the required operating conditions.The facility has committed to making the necessary improvements to their water quality.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: AMSCO 400 STEAM 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 ; 4402597401
• MDR Report Key: 22345828
• Report Number: 3005899764-2025-00052
• Device Sequence Number: 4888968
• Product Code: FLE
• UDI-Device Identifier: 00724995209490
• UDI-Public: (01)00724995209490(11)210928
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K212424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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
• Device Model Number: AMSCO 400 STEAM STERILIZER
• Device Catalogue Number: SR0201113311
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2021
• 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