MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. WM-NP2 WORKSTATION SET 1 (US); WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10021764

Device Problem Fire (1245)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

Due diligence for additional information was executed.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event, during preparation for use, when the device was being set up, there was a fire and smoke at the outlet when plugged into the cart.There was no injury or adverse impact to any person.There was no patient involvement.There was no damage to any devices or equipment on the tower.The power cord was changed out and everything worked properly thereafter.There were no issues noted with the cord prior to the procedure.As a precaution the tower was switched with another similar device for the set up.

Manufacturer Narrative

This device will not be returned.As such, the root cause of the issue cannot be determined conclusively.However, there is general review information for the device and issue that is available.This supplemental is being submitted to provide this information.Without evaluating the actual device, verification whether the issue was caused by the outlet or the power cable cannot be determined.The possibility exists that: there was a failure of the mains cable and/or its mains supply connector or there was a failure of the mains outlet socket in the user's facility or the mains cable had been pulled from the wall by repeated stressing of the mains cable (usually associated with moving the workstation while plugged in - contraindicated within the ifu) without the return of the device, there is no further information to definitively differentiate between these possibilities, however there is no known failure mechanism whereby a mains cable would function for five years and then spontaneously fail.It is thus suggested that the most probable cause is user error by omission of maintenance (by either of the users facilities or of the mains cable - specifically the wall plug) or by movement of the workstation while plugged in.

• Brand Name: WM-NP2 WORKSTATION SET 1 (US)
• 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: 10116317
• MDR Text Key: 193730647
• Report Number: 9611174-2020-00022
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• PMA/PMN Number: CLASS1-EXMP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: K10021764
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1