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

Model Number	5052
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee experienced a bruise on her arms and a concussion after the panel of their amsco 5052 single-chamber washer-disinfector fell.The employee was given zofran.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the top panel was loose due to a missing screw which obstructed the door from opening completely.To resolve the issue, the technician reinstalled the top panel.The unit was tested, confirmed to be operating according to specification, and returned to service.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: CART 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: 20556337
• Report Number: 9680353-2024-00035
• Device Sequence Number: 8979974
• Product Code: MEC
• UDI-Device Identifier: 00724995192969
• UDI-Public: (01)00724995192969(11)231221
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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: 5052
• Device Catalogue Number: FH14043
• 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: 09/30/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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