MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; AMSCO 2532 SINGLE-CHAMBER WASHER DISINFECTOR

Model Number	2532
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the observation of the fire, user facility personnel stated that the fire extinguished itself and contacted steris service.A steris service technician arrived onsite to inspect the amsco 2532 single-chamber washer disinfector and found the sump debris screen to not be seated correctly over the sump.The debris screen was sticking half up and half down subsequently causing the screen to contact the heaters resulting in the reported event.The technician stated that the unit's over-temperature switch operated properly shutting down power to the unit.The technician replaced the sump debris screen, tested the function and operation of the unit and confirmed the device was operating to specification.The technician counseled user facility personnel on the importance of checking the placement of the sump filter screen.The operator manual states (pg.17), "ensure the debris screen is securely installed prior to starting a cycle.Important: while reinstalling, slightly push on debris screen to ensure debris screen correctly rests on sump surface.No gap should be noted between the debris screen gasket and the sump surface." the amsco 2532 single-chamber washer disinfector was returned to service, and no additional issues have been reported.
Event or Problem Description
The user facility reported that a small fire and smoke were observed in the chamber of their amsco 2532 single-chamber washer disinfector during a cycle.No report of injury.

• Brand Name: AMSCO
• Common Device Name: AMSCO 2532 SINGLE-CHAMBER WASHER DISINFECTOR
• Manufacturer (Section D): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 23438827
• Report Number: 9680353-2025-00045
• Device Sequence Number: 15609698
• Product Code: MEC
• UDI-Device Identifier: 00724995192778
• UDI-Public: (01)00724995192778(11)220215
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/31/2025

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
• Operator of Device: Health Professional
• Device Model Number: 2532
• Device Catalogue Number: FH120102
• 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: 10/02/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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