MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 1215 CART WASHER/DISINFECTOR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Date 01/24/2024

Event Type  malfunction  

Event Description

The user facility reported that an employee slipped on water while pushing a cart into their amsco 1215 cart & utensil washer/disinfector.The employee sought and received medical treatment.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the amsco 1215 cart & utensil washer/disinfector and found that the unit was located on a sloped tiled floor with a previously existing drain at the deepest part of the slope.During the technician's inspection he found that the customer had filled in the previous drain with cement subsequently causing water to accumulate at the slope.The technician stated that the current drain location for the unit is in a corner and built on a slope making it difficult for water to drain.The steris service technician further inspected the amsco 1215 cart & utensil washer/disinfector and found that the door seals were out of adjustment.The technician confirmed that the door seals being out of adjustment were not related to the accumulation of water on the floor.The technician adjusted the door seals, tested the function and operation of the washer/disinfector and confirmed the unit to be operational.The user facility is responsible for repairing the floor drain location.The steris service technician advised user facility personnel to remove the cement from the pre-existing drain before returning the unit to service.No additional issues have been reported.

• Brand Name: AMSCO 1215 CART WASHER/DISINFECTOR
• Type of Device: WASHER/DISINFECTOR
• Manufacturer (Section D): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 18771386
• MDR Text Key: 336994712
• Report Number: 9680353-2024-00008
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1