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

Model Number	MST-H
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The component involved in the event is a thin long vertically mounted door frame panel that is secured by press-click type hardware.As the user maneuvered the cart, the panel was accidentally bumped out of place.The component was reattached by a service technician in accordance with the installation instructions.No manufacturing, workmanship or material deficiency has been identified.No adverse trends have been identified.The problem will be monitored and trended going forward.
Event or Problem Description
An employee was removing a case cart from the washer.The cart bumped the side panel of the door frame, causing it to fall off and hit the employee in the head.The employee was checked by in-house care and able to return to normal working schedule on the same day.

• Brand Name: CS 750
• 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: 16701043
• Report Number: 3001061128-2023-00004
• Device Sequence Number: 17063180
• Product Code: MEC
• UDI-Device Identifier: 07640141626146
• UDI-Public: (01)07640141626146(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: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 04/07/2023

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 Model Number: MST-H
• Device Lot Number: 2013530
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 04/07/2023
• 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