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

Model Number	7053HP
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the amsco 7053hp washer/disinfector and found that four adaptors that connect to the port connectors on the rack instrument holder were missing.As the adaptors were missing, this could have allowed the unit's jets to contact the unit's door seal resulting in the reported event.The washer/disinfector is not under steris service contract for maintenance activities and is serviced and maintained by the user facility.The routine maintenance guide in the steris operator manual recommends verifying the port connectors and flexible hoses on the rack instrument holder once a month.The technician made the necessary repairs, ran a test cycle, confirmed the unit to be operating according to specification and returned the unit to service.Steris performed in-service training on the proper use and operation of the unit and the importance of performing routine maintenance of the amsco 7053hp washer/disinfector.No additional issues noted.
Event or Problem Description
The user facility reported that their amsco 7053hp washer/disinfector was leaking water onto the floor.No report of injury.

• Brand Name: AMSCO
• Common Device Name: 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: 19732838
• Report Number: 9680353-2024-00024
• Device Sequence Number: 7006147
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2024

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: 7053HP
• Device Catalogue Number: FH19072
• 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: 06/14/2024
• Initial Report FDA Received Date: 07/12/2024
• 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