MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; CART WASHER/DISINFECTOR

Model Number	1215
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility observed that a "fly" was present between the glass panels of their amsco 1215 cart washer/disinfector.User facility personnel elected to remove the unit from service and postpone patient procedures.No report of injury.
Additional Manufacturer Narrative
A steris service technician inspected the amsco 1215 cart washer/disinfector and found an accumulation of water around the drain, resulting in the buildup of moisture and organic components subsequently leading to the presence of drain flies.The drain is located outside the footprint of the amsco 1215 cart washer/disinfector and is the user facility's responsibility to ensure proper drainage.The steris technician further inspected the unit and found a drain fly between the tempered glass doors of the unit.The unit's tempered glass doors consist of three layers with a gap between each layer.The drain fly was found in the outermost gap.The steris technician disassembled the tempered glass door panels to remove the drain fly and found no further issues.The technician cleaned the drain area, removed all drain flies and adjusted the drain to the floor level to facilitate proper drainage.User facility personnel were counseled on the importance of keeping the drain area clean and to ensure their amsco 1215 cart washer/disinfector has proper drainage.The amsco 1215 cart washer/disinfector was tested, confirmed to be operational and returned to service.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: CART 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: 20250578
• Report Number: 9680353-2024-00031
• Device Sequence Number: 17983299
• Product Code: MEC
• UDI-Device Identifier: 00724995214395
• UDI-Public: (01)00724995214395
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 09/18/2024

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
• Device Model Number: 1215
• Device Catalogue Number: FW12101
• 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: 08/19/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2022
• 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