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

Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and confirmed that the power supply was not working.The power supply is manufactured by a third-party supplier, siemens canada ltee, and steris has made them aware of the issue.The technician replaced the power supply, tested the unit, confirmed it to be operational, and returned it to service.The dhr for the unit was reviewed and confirmed it was manufactured according to specification.The power supply subject of the reported event is being returned for evaluation.A follow-up will be submitted when additional information become available.
Event or Problem Description
The user facility reported that the power supply of their amsco 7052hp washer/disinfector stopped working resulting in procedure cancellations.No report of injury.
Additional Manufacturer Narrative
The power supply subject of the event was returned to the supplier for evaluation and confirmed to be not operating properly.An exact cause of the observed malfunction could not be determined.

• Brand Name: AMSCO 7052HP WASHER/DISINFECTOR
• Common Device Name: 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: 17396621
• Report Number: 9680353-2023-00028
• Device Sequence Number: 18056811
• Product Code: MEC
• UDI-Device Identifier: 00724995176594
• UDI-Public: 00724995176594
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/26/2023

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
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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