MAUDE Adverse Event Report: BELIMED AG CS750; CART WASHER

Lot Number 27125

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Abrasion (1689)

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device was subject to testing by the manufacturer and no issues were found.The event can be traced to the user not following the instructions provided by the manufacturer.The cs750 user manual clearly instructs the user to always remove the key from the washer before entering the chamber in order to avoid becoming trapped inside or caught between closing doors.

Event Description

After introducing the cart into the washer and starting the machine, the user noticed that something needed to be adjusted and reentered the washer without pulling the key or pressing the emergency stop button.The user was aware of floor movements and thus of the fact that the machine had initiated the washing cycle.The closing doors caught the user's leg, causing minor scratches that healed without necessitating medical intervention.

• Brand Name: CS750
• Type of Device: CART WASHER
• Manufacturer (Section D): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer (Section G): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer Contact: heidi friesacher ; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• MDR Report Key: 18418223
• MDR Text Key: 331591669
• Report Number: 3001061128-2023-00010
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 27125
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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