MAUDE Adverse Event Report: STERIS CANADA CORPORATION RACK TO AMSCO 7053HP WASHER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the rack; however, the user facility could not identify the rack subject of the event.The facility has over 50 racks in use.Upon the technicians inspection of the washer and automated conveyor system, it was identified that the sensor in the conveyor system just in front of the washer door was misaligned, preventing it from properly sensing the racks.Instead of contacting steris for service, user facility personnel were manually pushing the racks into the washer.The amsco 7053hp washer operator manual states (1-2) "warning - personal injury hazard: when baskets are present on the conveyor modules, keep fingers and hands away from wash chamber doors and moving baskets." additionally, the operator manual states (1-1), "warning - personal injury and/or equipment damage hazard: repairs and adjustments to this equipment must be made only by steris or steris-trained service personnel.Contact steris regarding service options." the technician counseled user facility personnel on proper use and operation of the amsco 7053hp washer, specifically to keep hands away from moving racks, and to contact steris for service when needed.No additional issues have been reported.

Event Description

The user facility reported that an employee scraped their hand on a rack while pushing the rack into their amsco 7053hp washer.The employee applied a band aid and continued working.

• Brand Name: RACK TO AMSCO 7053HP WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 10762214
• MDR Text Key: 231800689
• Report Number: 9680353-2020-00033
• 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
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 09/30/2020
• 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