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

Model Number WD 290 IQ

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 316415851
• Report Number: 3001061128-2023-00007
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 07640141626177
• UDI-Public: (01)07640141626177(11)210129
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Model Number: WD 290 IQ
• Device Lot Number: 2013149
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2021
• 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