MAUDE Adverse Event Report: BELIMED AG WD 290 IQ; WASHER / DISINFECTOR

Lot Number	2014847
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Codes	Neck Pain (2433); Insufficient Information (4580)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While a hospital employee was trying to read just an incorrectly positioned, loaded rack that had already been placed inside the washer, the front top panel of the washer came loose and fell onto the employee's neck.He was injured but did not miss any workdays and was able to resume work shortly after the incident.
Additional Manufacturer Narrative
The loose panel was inspected and found to have been insufficiently secured with screws after a routine maintenance check conducted by the manufacturer's service team two weeks before the incident occurred.The panel has been reattached securely to the washer.
Additional Manufacturer Narrative
It has been confirmed that the injury to the employee was minor.The panel fell on his neck, causing pain from the impact, but he suffered no bruises, bumps, or any other specific type of injury.He was able to return to work the same day.The following fields were modified in this supplement report: b4, g3, g6, h2, h6, and h11.

• Brand Name: WD 290 IQ
• Common Device Name: WASHER / DISINFECTOR
• 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: 24159576
• Report Number: 3001061128-2026-00001
• Device Sequence Number: 9112758
• Product Code: MEC
• UDI-Device Identifier: 07640141626177
• UDI-Public: (01)07640141626177(11)211206
• 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,Followup
• Report Date (Section B): 03/24/2026

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: 2014847
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• 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