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

Model Number	7052HP
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The steris technician arrived onsite and performed troubleshooting on the amsco 7052hp washer-disinfector, no repairs were required.The technician cleaned the rinse reservoir to resolve the issue.The steris technician tested the unit, confirmed it to be operational, and returned it to service.The amsco 7052hp maintenance manual (764337483 rev e) states, "6.100 alarm #51 rinse reservoir- condition: alarm is triggered when reservoir over temperature switch (ots) is tripped and cycle is running.Advanced troubleshooting: clean or replace level sensor." the steris account manager contacted the user facility to offer counseling on the proper troubleshooting techniques to the amsco 7052hp washer-disinfector; however, the user facility has declined.No additional issues have been reported.
Event or Problem Description
The user facility reported the rinse reservoir overtemperature alarm to their amsco 7052hp washer-disinfector was "tripped" and not working properly.The unit was removed from service to await onsite inspection; subsequently attributing to a procedure delay.No report of injury.

• 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: 20475835
• Report Number: 9680353-2024-00034
• Device Sequence Number: 7519421
• Product Code: MEC
• UDI-Device Identifier: 00724995176594
• UDI-Public: (01)00724995176594(11)240702
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/17/2024

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: 7052HP
• Device Catalogue Number: FH18043
• 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: 09/23/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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