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

Model Number	7053HP
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the washer and found that the fittings below the flow meters were loose resulting in liquid leaking onto the floor.The technician removed, cleaned, and retightened the fittings, tested the unit, confirmed it to be operating according to specifications, and returned it to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee slipped and fell on soap leaking from their amsco 7053hp washer/disinfector resulting in an injury (concussion).The employee sought and received medical treatment.

• 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 road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 16396116
• Report Number: 9680353-2023-00007
• Device Sequence Number: 20168646
• Product Code: MEC
• UDI-Device Identifier: 00724995176662
• UDI-Public: 00724995176662
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 02/17/2023

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: 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: 01/18/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2019
• 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