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

Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility stated in medwatch # (b)(4) that the panels on the unload side of the amsco 7052hp washer/disinfector were damaged during installation.The damage observed by user facility personnel was an aesthetic issue and had no impact on the function or operation of the unit.The steris installation team repaired the damaged panels during the time of installation.The user facility further reported that following installation of the amsco 7052hp washer/disinfector the unit began to experience a recurrent "alarm 28: unload door did not close (non-critical)".User facility personnel stated the alarm 28 required several service requests and caused the unit to run at a reduced rate while awaiting repairs.No procedure delays/cancellations were reported.The date of event stated in the medwatch # (b)(4) was (b)(6) 2023.Steris completed all repairs on july 13, 2023, and returned the unit to service.Steris received medwatch # (b)(4) on october 5, 2023.No additional issues or service requests have been reported since july 13, 2023.
Event or Problem Description
The user facility reported via medwatch # (b)(4) that after steris's installation of the amsco 7052hp washer/disinfector, the unit was experiencing a lot of "problems".No report of injury.

• Brand Name: AMSCO 7052HP 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: 18062243
• Report Number: 9680353-2023-00037
• Device Sequence Number: 7427505
• Product Code: MEC
• UDI-Device Identifier: 00724995176563
• UDI-Public: 00724995176563
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/02/2023

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: 10/05/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• 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