MAUDE Adverse Event Report: BELIMED AG CS 750 WAY; CART WASHER

Lot Number	2013530
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The allegedly malfunctioning washer was inspected, but no leaks from the unit were found.The service technician has run multiple cycles and no leaks have occurred.It has not been possible to confirm the problem reported by the healthcare facility.The service technician will continue to monitor the unit moving forward.If additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
According to the healthcare facility, soapy water was leaking from the top of the washer down to the floor.A technician slipped and fell, but was not reported to have been injured or to need medical attention.

• Brand Name: CS 750 WAY
• Common Device Name: 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: 22440758
• Report Number: 3001061128-2025-00005
• Device Sequence Number: 4670151
• Product Code: MEC
• UDI-Device Identifier: 07640141626139
• UDI-Public: (01)07640141626139(11)210317
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Lot Number: 2013530
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown