MAUDE Adverse Event Report: STERIS RELIANCE CART AND UTENSIL WASHER/DISINFECTOR; WASHER OF BODY WASTE RECEPTACLES

Model Number 1227 FW03-101

Device Problem Insufficient Information (3190)

Patient Problems Physical Entrapment (2327); Injury (2348)

Event Date 06/05/2015

Event Type  No Answer Provided  

Event Description

Employees are sustaining hand injuries when removing carts from the cart washer.Their hands are getting caught between the cart and door when unloading.No handles are attached.

• Brand Name: RELIANCE CART AND UTENSIL WASHER/DISINFECTOR
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): STERIS; 5960 heisley road; menton OH 44060
• MDR Report Key: 4852674
• MDR Text Key: 5805774
• Report Number: 4852674
• Device Sequence Number: 1
• Product Code: FLH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Other
• Device Model Number: 1227 FW03-101
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1