MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 7052HP WASHER/DISINFECTOR

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

Following the reported event, the customer inspected the washer and found damage to the condensate return line allowing water to leak from the unit onto the floor.In addition, the customer identified that the washer's hose was damaged.The customer completed the repairs and returned the unit to service.A steris technician arrived onsite and confirmed the repairs have been made and the unit is operational.The dhr was reviewed for the unit and was found to be manufactured per specifications.A review of past complaints confirms this to be an isolated incident.No additional issues have been reported.

Event Description

The user facility reported that water was leaking from their amsco 7052hp washer onto the floor.No report of injury.

• Brand Name: AMSCO 7052HP 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: 18914431
• MDR Text Key: 337793325
• Report Number: 9680353-2024-00013
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 00724995176570
• UDI-Public: 00724995176570
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2023
• 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