MAUDE Adverse Event Report: BELIMED INFECTION CONTROL / BELIMED AG BELIMED CASE CART WASHERS; WASHER OF BODY WASTE RECEPTACLES

Model Number CS750-L-2-V1-D-2-R-N

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2022

Event Type  malfunction  

Event Description

Two belimed case cart washers with numerous mechanical issues that have not been properly repaired by the company.The repair person has been to our location at least three times with only temporary fixes that are not inline with the manufacturer's recommendations.We are still awaiting for the appropriate correction of the problems.The main issues are related to steam supply line integrity, steam relief valve integrity, and water leaks from the sealed doors.These issues were elevated within the company without resolution.Fda safety report id # (b)(4).

• Brand Name: BELIMED CASE CART WASHERS
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): BELIMED INFECTION CONTROL / BELIMED AG
• MDR Report Key: 13252111
• MDR Text Key: 283949343
• Report Number: MW5106638
• Device Sequence Number: 2
• Product Code: FLH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/11/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CS750-L-2-V1-D-2-R-N
• Device Catalogue Number: CS750-L-2-V1-D-2-R-N
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1