MAUDE Adverse Event Report: BELIMED AG BELIMED WASHER/DISINFECTOR WD750

Model Number WD750

Device Problem Unintended System Motion (1430)

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

Event Date 10/14/2022

Event Type  malfunction  

Event Description

After conclusion of the washing process, an operator entered the washer to unload the racks.As the operator was retrieving the second rack, the door to the washer shut on its own accord without any intervention by the operator or another person.The machine did not initiate the washing process.The operator pressed the emergency stop button inside the chamber and the pressure was released from the door seal, allowing other staff members to open the door manually from the outside.The operator was not hurt or injured in any way, other than the initial fear experienced upon being shut in the washer chamber.Later in the day the staff observed the door to the washer closing of its own accord again.The second time no one was inside the chamber.The washer was taken out of service and a technician was called.

Manufacturer Narrative

The device door mechanism is controlled by an hmi on the loading side of the washer.The hmi was replaced and the device has been put back in service with the new hmi without any problems.The hmi that was involved in the event has been returned to its manufacturer for inspection.Upon conclusion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The hmi installed at the time of the event was tested by the manufacturer and found to conform to specifications.The cause of the incident has been traced to a "ghost touch" activating the door via the operating panel, the first such case of which the manufacturer has become aware.Multiple factors need to present simultaneously for this effect to occur, thus making it exceedingly rare.A risk assessment has been performed and the problem will be monitored going forward.

• Brand Name: BELIMED WASHER/DISINFECTOR WD750
• 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: 15820357
• MDR Text Key: 303917039
• Report Number: 3001061128-2022-00012
• Device Sequence Number: 1
• Product Code: MEC
• 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,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: WD750
• Device Lot Number: 2012434
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2020
• 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