MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 7053HP WASHER/DISINFECTOR

Model Number	7053HP
Medical Device Problem Codes	Leak/Splash (1354); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the amsco 7053hp washer/disinfector and found that water had leaked from the air filter.No issues were noted with the function or operation of the washer.No repairs or adjustments were required.The technician stated that the facility's air compressor failed and pumped water through the air supply line to the unit subsequently causing water to leak out of the washer's air filter.The user facility is responsible for the air compressor and made necessary repairs to the equipment; the air compressor was returned to service.The steris service technician confirmed the amsco 7053hp washer/disinfector was operating properly and returned the unit to service.A complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that water was leaking from their amsco 7053hp washer/disinfector onto the floor.No report of injury.

• Brand Name: AMSCO 7053HP WASHER/DISINFECTOR
• Common Device Name: 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: 17181794
• Report Number: 9680353-2023-00021
• Device Sequence Number: 15077005
• Product Code: MEC
• UDI-Device Identifier: 00724995176662
• UDI-Public: 00724995176662
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: 7053HP
• Device Catalogue Number: FH19042
• 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: 05/26/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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