MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. WM-DP2 WORKSTATION SET 3 (ROW); WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10022949

Device Problems Melted (1385); Device Emits Odor (1425); Defective Device (2588)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/19/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect device has not been returned to olympus keymed for investigation/evaluation.Olympus keymed have requested the return of the transformer/power cable.

Event Description

Staff noticed a burning electrical smell.The maintenance team at the facility checked the workstation over and found there was a faulty socket on the transformer.Part of the plug and cord that was plugged into it had melted.The trolley is safe to use but the facility would like a new transformer.

Manufacturer Narrative

The outcome of the olympus keymed investigation was that the event occured due to an incorrect installation and was not caused by a manufacturing issue.The photos provided show that the wm-np2 workstation was installed using an orange power cable (olympus power cables are grey).Information provided sufficient.

• Brand Name: WM-DP2 WORKSTATION SET 3 (ROW)
• Type of Device: WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.; keymed house, stock road; southend-on-sea, essex SS2 5 QH; UK SS2 5QH
• MDR Report Key: 9928137
• MDR Text Key: 202556892
• Report Number: 9611174-2020-00016
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• PMA/PMN Number: CLASS 1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: K10022949
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1