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

Device Problems Sparking (2595); Insufficient Information (3190)

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

Event Date 11/09/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the amsco 7052hp washer/disinfector and found that the unit was not operational.The washer has been removed from service; a replacement washer will be provided to the user facility.The key components from the washer will be returned to steris for evaluation.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported sparks were emitting from the top of their amsco 7052hp washer/disinfector.No report of injury.

Manufacturer Narrative

Based on the evaluation, the root cause of the event would appear to be attributed to the screw from the trap assembly becoming loose.This caused the top of the sump to detach and allowed the fan assembly to slip down causing the reported event.The unit is not under steris agreement for maintenance, the user facility is responsible for all maintenance activities.A 3-year complaint review confirmed this to be an isolated event.The user facility has been provided with a replacement washer.No additional issues have been reported.

• Brand Name: AMSCO 7052HP 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 road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 12967526
• MDR Text Key: 286541438
• Report Number: 9680353-2021-00047
• Device Sequence Number: 1
• Product Code: MEC
• 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,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2021
• 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