MAUDE Adverse Event Report: BELIMED AG BELIMED CART WASHER; WASHER OF BODY WASTE RECEPTACLES

Model Number CS750

Device Problem Defective Component (2292)

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

Event Date 02/07/2022

Event Type  malfunction  

Event Description

Cart washer is not meeting the required temperature threshold and will not pass the required test for operation.Cart washer taken out of service.Fda safety report id # (b)(4).

Event Description

Cart washer is not meeting the required temperature threshold and will not pass the required test for operation.Cart washer taken out of service.Fda safety report id # (b)(4).

• Brand Name: BELIMED CART WASHER
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): BELIMED AG
• MDR Report Key: 13505965
• MDR Text Key: 285529254
• Report Number: MW5107346
• Device Sequence Number: 1
• 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: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS750
• Device Catalogue Number: CS750
• Device Lot Number: T0033586
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1