MAUDE Adverse Event Report: BELIMED AG WD290 IQ; WASHER DISINFECTOR

Model Number	WD 290 IQ
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A metal clamp intended to fasten the water drain tube to the device was tightened excessively during assembly, cutting the tube material.The cut was not visible, being covered by the clamp itself.After seven months of routine use, the tube started to leak.The damaged component has been replaced and the device is functioning normally.
Event or Problem Description
The plastic drain of the washer was damaged by the hose clamp, producing a deep cut that started to leak and flooded the floor of the cssd around the device.

• Brand Name: WD290 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: 17050158
• Report Number: 3001061128-2023-00007
• Device Sequence Number: 3455461
• Product Code: MEC
• UDI-Device Identifier: 07640141626177
• UDI-Public: (01)07640141626177(11)210129
• 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): 06/02/2023

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: WD 290 IQ
• Device Lot Number: 2013149
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• 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