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

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2023

Event Type  malfunction  

Event Description

The user facility reported via medwatch mw5119138, that preventive maintenance (pm) on their amsco 7053l washer/disinfector was unable to be completed due to pm parts being on backorder.

Manufacturer Narrative

The user facility contacted steris via service request on (b)(6) 2023, to perform preventive maintenance activities for their amsco 7053l washer/disinfector.Steris schedules service activities (repair and preventive maintenance) based on availability of service technicians.Pm activities are prioritized for customers on a steris service contract.The amsco 7053l washer/disinfector at (b)(6) is not under a service contract with steris.The user facility is responsible for service and all preventive maintenance activities for the equipment.Contrary to the reported event the service parts needed to complete the pm activity were not on backorder.Due to the steris service technician's availability, the preventive maintenance activities for the subject amsco 7053l washer/disinfector were scheduled and completed on (b)(6) 2023.In-between the service request activity on (b)(6) 2023, and the preventive maintenance activity on (b)(6) 2023, user facility personnel continued to use the amsco 7053l washer/disinfector as no issues were noted with the function or operation of the device.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.

• Brand Name: AMSCO 7053L WASHER/DISINFECTOR
• Type of Device: 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: 17499890
• MDR Text Key: 321719075
• Report Number: 9680353-2023-00030
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 00724995193119
• UDI-Public: 00724995193119
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/10/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1