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

Model Number	2532
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event.The technician inspected the amsco 2532 single-chamber washer disinfector and found that a hose clamp required tightening on the recirculation pump.The technician tightened the hose clamp, ran a test cycle and confirmed the unit to be operating to specifications.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 water was leaking from their amsco 2532 single-chamber washer disinfector onto the floor.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
• MDR Report Key: 21415436
• Report Number: 9680353-2025-00006
• Device Sequence Number: 9327992
• Product Code: MEC
• UDI-Device Identifier: 00724995192761
• UDI-Public: (01)00724995192761(11)220920
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/19/2025

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: FH120101
• 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: 01/21/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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